Source: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm297823.htm
Timestamp: 2016-08-27 02:52:33
Document Index: 411972838

Matched Legal Cases: ['art 2', 'art 3', 'art 1', 'art 2', 'art 1', 'art 2', 'art 2', 'art 1', 'art 2', 'art 3']

Enforcement Report for March 28, 2012 Skip to main page content
Publix brand Beef Stew Mix, 1.5 oz pouches, Ampacco Item Number: 900080204, further packaged in cartons labeled as Publix Brown Gravy with Onion Mix; pouches are labeled in part ***UPC 41415-03608. Recall # F-0926-2012
BEST BY DEC 09 13 H
McCormick & Company, Inc., Hunt Valley, MD, by press release on March 9, 2012. Firm initiated recall is ongoing.
Food product was filled into incorrect pouches, which do not declare a milk ingredient on the label.
Backroad Country Caramel Puffcorn, a) 8 oz and b) 16 oz clear plastic bags. 8 oz UPC 0 49646 90176 0, 16 oz UPC 0 49646 90158 6. Recall # F-0925-2012
a) Sell By Date/Lot Code: 03/07/12 C1P16, 03/21/12, B2Y16, 05/16/12 B1X16, 05/30/12 B1X16 & 06/13/12 A3K16; b) Sell By Date/Lot Code: 03/07/12 C1P16, 03/21/12 B2Y16, 05/16/12 B1X16, 05/30/12 B1X16 & 06/13/12 A2R16 or A3K16
Recalling Firm: Troyer Cheese, Inc., Millersburg, OH, by telephone on March 3, 2012 and letter on March 17, 2012.
Manufacturer: Axium Foods, Division of McCleary, Inc., South Beloit, IL. FDA initiated recall is ongoing.
During an FDA inspection the firm was notified that their ingredient stated lack the required "milk" declaration on their ingredient statement.
260 cs/8 oz plastic bags & 633 cs/16 oz plastic bags
Sea Wealth Frozen Whole Round Striped Bass, 500-800g. Recall # F-0927-2012
Lot #B74376
Recalling Firm: Sea Wealth Products, Inc., Alhambra, CA, by telephone on February 29, 2012 and by letters on March 9, 2012 and March 13, 2012.
Manufacturer: Union Development Frozen Foods Co., Ltd., Kaohsiung, Taiwan. Firm initiated recall is ongoing.
The frozen striped bass may be contaminated with Salmonella.
480 cartons
1) French Bread, Net Wt 16 oz (1 lb) 454 grams. UPC: 075551411469. Recall # F-0928-2012;
2) Bimbo Sourdough French Bread, clear label, 6 units per tray, Net Wt 16 ozs. (454 grams); UPC: 075551411490. Recall # F-0929-2012;
3) Ozark Hearth Sourdough Bread, Net Wt. 20 oz. (1 lb. 4 oz’s.) 567 G; UPC 075551500019. Recall # F-0930-2012;
4) Sourdough French Bread, Clear plastic bag with stick-on label, Net Wt 20 oz’s. (567 grams). UPC 075551411261. Recall # F-0931-2012
1) Lot Numbers: 026, 028, 029, 030, 031, 033, 035, and 038;
2) Lot numbers 022 and 026;
3) Use by date Feb 8, 10, 12 and 16, 2012;
4) Lot Number 029
Harris Baking Co., Rogers, AR, by telephone on February 10, 2012. Firm initiated recall is ongoing.
The product has the potential to contain foreign material.
31,782 units
1) Vita HERRING IN REAL SOUR CREAM KEEP REFRIGERATED, a) Net Wt 8 oz, UPC 022635400154; b) 30 oz UPC 022635417411. Recall # F-0932-2012;
2) Vita SLICED LUNCH HERRING KEEP REFRIGERATED PACKED IN U.S.A. Net Wt 8 oz. UPC 022635409744. Recall # F-0933-2012;
3) Vita HOMESTYLE HERRING KEEP REFRIGERATED PACKED IN U.S.A. Net Wt 32 oz. UPC 022635409805. Recall # F-0934-2012;
4) Vita Premium Horseradish Prepared KEEP REFRIGERATED. Net Wt. 5 oz. UPC 022635430120. Recall # F-0935-2012;
5) Vita HERRING IN WINE SAUCE KEEP REFRIGERATED PACKED IN U.S.A. NET WT. a) 8 oz., UPC: 022635400024; b) 12 oz, UPC 022635400031 and c) 32 oz. UPC 022635400116. Recall # F-0936-2012;
6) Tabatchnick Yankee Bean Soup Net Wt 15 oz. Keep Frozen,
UPC 071262294919. Recall # F-0937-2012;
7) Divina Olives Stuffed with Feta Cheese Net Drained Wt. 4 oz Keep Refrigerated Product of Greece. ITEM # 52780, UPC 631723527804. Recall # F-0938-2012;
8) Divina Olives Stuffed with Blue Cheese Net Drained Wt 4 oz Keep Refrigerated Product of Greece, Item # 52790, UPC 631723527903. Recall # F-0939-2012;
9) Gente Foods Black Bean Gorditas 3 Handmade Filled Thick Tortillas Net Wt 10 oz Perishable Keep Refrigerated, UPC 618032102021. Recall # F-0940-2012;
10) Albert's Famous Mexican Hot Sauce Mild Refrigerated For Freshness Net Weight 32 Ounces - UPC 073816-320143 Net Weight 16 ounces - UPC 073816-160138. Recall # F-0941-2012;
11) Albert's Famous Mexican Hot Sauce Medium Net Weight 16 ounces, UPC 073816-160152. Recall # F-0942-2012
1) a) Lot: 120128 30 oz; b) Lot code 120216;
2) Lot: 120819;
3) Lot: 120901;
4) Lots 111226 & 120826;
5) a) Lot: 120818; b) Lot: 120802: c) Lot: 120826;
6) Date code 05-04-14;
7) Best Used By: 11JAN2012 & 01FEB2012;
8) Best Used by: 11JAN2012, 01FEB2012, 15DEC2011, and 30DEC2011
9) Best Used By 11/06/11;
10) Exp date 05/16/12 and 06/02/12;
11) Exp date 06/27/12
Recalling Firm: UNFI General Corp., Providence, RI, by telephone on October 20, 2011 and press releases on November 9, 2011, November 10, 2011, November 14, 2011 and November 17, 2011.
Manufacturers: Foodmatch Inc., New York, NY;
Tabatchnick Fine Foods, Inc., Somerset, NJ;
Jananna Foods, Inc., Kilgore, TX;
Tortilleria El Molino, Concord, CA. Firm initiated recall is ongoing.
The product was not stored according to label directions and has the potential to be contaminated.
TX, CA, AK, WA, OR, NV, CO, WY, SD, and AZ
1) Custard Cream Bread Ingredients: Custard Cream, Flour (Bleached wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Butter (pasteurized cream natural flavoring), Sugar, Egg, Yeast, Salt. Net Wt 3oz. This item contains milk. Recall # F-0943-2012;
2) Taro Sponge Cake Taro, Flour, Sugar, Egg, Butter Wt 3.5 oz. Recall # F-0944-2012;
3) Taro Cream Bread - A label for this product could not be collected. The firm did not have labeling for this product during the inspection, and the investigator that conducted the inspection is no longer with the FDA. Recall # F-0945-2012;
4) Cream Cheese Bread Ingredients: Cream Cheese, Flour (Bleached wheat flour, malted barley, flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Butter (pasteurized cream natural flavoring), Sugar, Egg, Yeast, Salt. Net Wt 2 oz / 56 g. Recall # F-0946-2012
All products sold prior to 04/28/2011.
Inchon Food Co., Irving, TX, by telephone on April 28, 2011. FDA initiated recall is ongoing.
The product contains undeclared Yellow # 5 and Yellow # 6, Red # 40 and Red # 3.
1) 80 units; 2) approximately 100 units; 3) approximately 90 units; 4) 100 units
1) Creekside Grains, Heirloom Applesauce Cake, Nt. Wt 22 oz, Ingredients unbleached flour, sugar baking powder, baking soda, cinnamon, salt, and ginger. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0947-2012;
2) Creekside Grains, Kahlua and Cream Scone Baking Mix, Nt. Wt 16 oz, Ingredients: unbleached flour, sugar, chocolate chips( sugar chocolate, cocoa butter, milkfat, soy lecithin), baking powder, baking soda, raw sugar, salt. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0948-2012;
3) Creekside Grains, Apple Crisp Baking Mix, Nt. Wt 16 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, cloves, cinnamon, nutmeg, ginger. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0949-2012;
4) Creekside Grains, Cherry Crunch Baking Mix, Nt. Wt 13 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, pecans, ginger, cinnamon, salt, dried cherries. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0950-2012;
5) Creekside Grains, Blueberry Crunch Baking Mix, Nt. Wt 13 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, pecans, ginger, cinnamon, salt, dried blueberries . Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0951-2012;
6) Creekside Grains, Peach Crunch Baking Mix, Nt. Wt 13 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, pecans, ginger, cinnamon, salt. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0952-2012;
7) Creekside Grains, Black Cherry Walnut Cookies Baking Mix, Nt. Wt 20 oz, Ingredients: unbleached flour, sugar, baking soda, baking powder, salt dried cherries, walnuts, black cherry extract (water artificial flavor, caramel color, sodium benzoate) . Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0953-2012
Expiration date stamped on packages 07012012-03052013.
Creekside Grains, Traverse City, MI, by telephone beginning March 5, 2012, E-mail, in person, or letter beginning March 12, 2012. Michigan initiated Recall is ongoing.
Some Creekside Grains Cake and Baking Mixes do not include wheat (an allergen) and malted barley as the source of the flour.
1.000 boxes of each product
1) Enoxaparin Sodium Injection, USP, 100 mg/mL, 1 mL pre-filled Single Dose Syringe in a blister (NDC 0781-3500-05) packaged in 10-count Syringes in a blister per carton (NDC 0781-3500-69), Rx Only. Recall # D-1274-2012;
2) Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, 0.3 mL pre-filled Single Dose Syringe in a blister, NDC 0781-3133-01, packaged in 10-count Syringes in a blister per carton, NDC 0781-3133-63, Rx Only. Recall # D-1275-2012
1) Lot #: 917713, Exp 08/13;
2) Lot #: 917995, Exp 08/13
Recalling Firm: Sandoz Inc., Broomfield, CO, by letters on February 13, 2012.
Manufacturer: Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN. Firm initiated recall is ongoing.
Defective Container: Small defects with stopper ribs.
100 mg: 27,059 cartons; 30 mg: 15,051 cartons
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0567-12;
2) Fresh Frozen Plasma (Apheresis). Recall # B-0568-12
1) Units: W117011455969F Part A; W117011456611M Part A; W117011456611M Part B; W117011455969F Part B; W117011450914E Part A; W117011450914E Part B;
2) Units: W117011455969F; W117011456611M; W117011450914E
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone and letter on January 3, 2012. Firm initiated recall is complete.
Red Blood Cells Leukocytes Reduced. Recall # B-0569-12
Unit: W038111251841
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter on December 27, 2011.
Manufacturer: Florida's Blood Centers, Inc., Altamonte Springs, FL. Firm initiated recall is complete.
Red Blood Cells. Recall # B-0829-12
Units: W036811205007 (part A); W036811205007 (part B)
Community Blood Centers Laboratory Services, Inc., Lauderhill, FL, by telephone on September 8, 2011 and letter on September 13, 2011. Firm initiated recall is complete.
Apheresis Platelet Leukoreduced Irradiated. Recall # B-0858-12
Unit: W044111132929
LifeServe Blood Center, Des Moines, IA, consignee by telephone on January 6, 2012 and by letter on January 12, 2012. Firm initiated recall is complete.
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
Plasma Frozen within 24 hours (FP24). Recall # B-0859-12
Unit: 53GN94459
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile and telephone on December 14, 2011. Firm initiated recall is complete.
Red Blood Cells Leukocytes Reduced. Recall # B-0862-12
Unit: W051511125558
Memorial Blood Centers, Saint Paul, MN, by facsimile on December 5, 2011. Firm initiated recall is complete.
Red Blood Cells Leukocytes Reduced. Recall # B-0863-12
Unit: W051511130331
Memorial Blood Centers, Saint Paul, MN, by facsimile on December 19, 2011. Firm initiated recall is complete.
Source Plasma. Recall # B-0869-12
Unit: 11HINC4208
Bio-Blood Components, Inc., Hammond, IN, by fax on December 22, 2011. Firm initiated recall is complete.
Blood product collected from a donor whose scheduled physical exam had not been performed, was distributed.
Source Plasma. Recall # B-0870-12
Unit: GZ081879
Bio-Blood Components, Inc., Gary, IN, by fax on November 11, 2011. Firm initiated recall is complete.
Blood product, collected from a donor who was previously deferred for high risk behavior, was distributed.
Red Blood Cells Leukocytes Reduced. Recall # B-0871-12
Unit: W053311701819
Community Blood Center, Inc., Appleton, WI, by letter dated January 13, 2012. Firm initiated recall is complete.
Wisconsin; Switzerland
Red Blood Cells Leukocytes Reduced. Recall # B-0875-12
Units: W043811009799; W043811009671
LifeShare Community Blood Services, Elyria, OH, by telephone on December 19, 2011 and fax on December 28, 2011. Firm initiated recall is complete
Red Blood Cells Leukocytes Reduced. Recall # B-0876-12
Unit: W037711169932
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated December 28, 2011. Firm initiated recall is complete.
Blood product, collected from a donor who reported travel to a malaria endemic area, was distributed.
1) Red Blood Cells. Recall # B-0877-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0878-12
1) and 2) Unit: W038111262848
Florida's Blood Centers, Inc., Melbourne, FL, by telephone and letter on December 20, 2011 and follow-up letter on January 26, 2012. Firm initiated recall is complete
Blood products, collected from a donor who engaged in multiple high risk behaviors, were distributed.
1) Fresh Frozen Plasma. Recall # B-0893-12;
2) Red Blood Cells. Recall # B-0894-12
1) Unit: 0013983;
2) Units: 2173901; 0013983
Community Blood Centers of Florida, Inc., Miami, FL, by telephone and letter on January 11, 2012. Firm initiated recall is complete.
Cryoprecipitated AHF, Recall # B-0895-12
Units: W021611105475; W021611105476; W021611105477; W021611105480; W021611105481; W021611105499; W021611105484; W021611105490; W021611105510; W021611105515; W021611105527; W021611105525
Department of the Navy, San Diego, CA, by telephone on November 24, 2011 and by letter on December 1, 2011. Firm initiated recall is complete.
AZ, NJ, CA
1) Red Blood Cells Leukocytes Reduced. Recall # B-0896-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0898-12
1) 29KL65329;
2) Units: 29KL65328; 29GT89842; 29GT91007; 29GY82425; 29GY82994; 29KE88471; 29KL65334
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on December 8, 2011. Firm initiated recall is complete.
Blood products, collected from donors who were not appropriately questioned regarding CJD risk, were distributed.
Red Blood Cells. Recall # B-0900-12
Unit: KP77977
San Diego Blood Bank, San Diego, CA, by telephone on July 17, 2007. Firm initiated recall is complete.
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0901-12
Unit: 9167276
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on June 12, 2006. Firm initiated recall is complete.
Blood product, for which there was incomplete documentation of the irradiation process, was distributed.
1) Fresh Frozen Plasma. Recall # B-0903-12
2) Fresh Frozen Plasma (Apheresis). Recall # B-0904-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0905-12;
4) Red Blood Cells. Recall # B-0906-12;
5) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0907-12;
6) Platelets Pheresis Leukocytes Reduced. Recall # B-0908-12;
7) Red Blood Cells Leukocytes Reduced. Recall # B-0910-12
1) Unit: 6812209;
2) Units: 9175026, 9175027;
3) Unit: 9414035;
4) Units: 2107582, 2107583, 2107586, 2107587, 2107890, 2107892, 2107895, 2107900, 6803365, 6803371, 6804632, 6804640, 6808879, 6808880, 6808883, 6808884, 6808891, 6808892, 6808898, 6808900, 6809414, 6809416, 6809418, 6809419, 9129202, 9129203, 9129204, 9129205, 9129206, 9129207, 9129208, 9129209, 9129210, 9129211, 9129213, 9129214, 9129215, 9129216, 9129217, 9129218, 9129219, 9129220, 9129221, 9129222, 9129223, 9129225, 9129226, 9129227, 9129228, 9129229, 9129230, 9129231, 9129232, 9129234, 9129235, 9129236, 9129238, 9129239, 9129240, 9129241, 9129242, 9129243;
5) Units: 9175025;
6) Units: 9175025 Part 2, 9175025 Part 3, 9175026, 9175027 Part 1, 9175027 Part 2, 9175028 Part 1, 9175028 Part 2, 9175030, 9175032 Part 2;
7) 2107577, 2107578, 2107579, 2107581, 2107582, 2107583, 2107586, 2107587, 2107886, 2107887, 2107888, 2107889, 2107890, 2107891, 2107892, 2107894, 2107895, 2107896, 2107897, 2107898, 2107899, 2107900, 2107901, 2107902, 2107903, 2107904, 2107906, 2107907, 2107909, 2107910, 2107911, 2107912, 2107913, 2107914, 2107915, 2107916, 6803363, 6803364, 6803365, 6803366, 6803367, 6803368, 6803369, 6803370, 6803371, 6803372, 6803373, 6803374, 6804625, 6804626, 6804627, 6804628, 6804631, 6804632, 6804634, 6804635, 6804636, 6804637, 6804638, 6804639, 6804640, 6804641, 6804642, 6808875, 6808876, 6808877, 6808878, 6808879, 6808880, 6808881, 6808882, 6808883, 6808884, 6808885, 6808886, 6808887, 6808889, 6808890, 6808891, 6808892, 6808893, 6808895, 6808896, 6808897, 6808898, 6808899, 6808900, 6809414, 6809416, 6809417, 6809418, 6809419, 6809420, 6809421, 6809422, 6809423, 6809424, 6809425, 6809426, 6809427, 6809428, 6809429, 6809431, 6812202, 6812203, 6812204, 6812205, 6812206, 6812207, 6812208, 6812210, 6812211, 6812212, 9129202, 9129203, 9129204, 9129205, 9129206, 9129207, 9129208, 9129209, 9129210, 9129211, 9129212, 9129213, 9129214, 9129215, 9129216, 9129217, 9129218, 9129219, 9129220, 9129221, 9129222, 9129223, 9129225, 9129226, 9129227, 9129228, 9129229, 9129230, 9129231, 9129232, 9129233, 9129234, 9129235, 9129236, 9129238, 9129239, 9129240, 9129241, 9129242, 9129243, 9129322, 94149035
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 21, 2007. Firm initiated recall is complete.
Blood products, tested for anti-HBc and HCV using expired reagents, were distributed.
AK, CA, CO, FL, KS, IL, MO, NJ, NY, TN, and Switzerland
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0911-12;
2) Cryoprecipitated AHF. Recall # B-0912-12;
3) Recovered Plasma. Recall # B-0913-12
1), 2), 3) Unit: 5201676
Recalling Firm: New York Blood Center, Inc., New York, NY, by letter on November 13, 2006.
NY, Switzerland
Platelets Pheresis Leukocytes Reduced Recall # B-0918-12
Units: 6507720 Unit A; 6507720 Unit B
Recalling Firm: New York Blood Center, Inc. New York, NY, by letter on October 17, 2006 and facsimile on November 1, 2006.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete.
Blood Products, whichdid not meet acceptable product specifications, were distributed.
Platelets Pheresis Leukocytes Reduced. Recall # B-0919-12
Units: 6415283 (BAG2); 6415283 (BAG1)
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on March 18, 2007 and by facsimile on March 23, 2007.
Blood products, which were possibly contaminated with bacillus species, were distributed.
Source Plasma. Recall # B-0923-12
Units: 391057127, 391055830, 391055410, 391054960, 391054517, 391054094, 391053700, 391053301, 391052940, 391052622, 391051878, 391051851, 391051016, 391050866, 391047374, 391047273, 391058441, 391057961, 391046657, 391046438, 391045712, 391045475, 391044805, 391044540, 391042652, 391042491, 391041312, 391039791, 391039321, 391038720, 391028908, 391028863
Talecris Plasma Resources, Inc., N Las Vegas, NV, by facsimile on June 2, 2008. Firm initiated recall is complete.
Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0933-12
Units: 106684462 (2 units)
Blood Systems, Inc., Scottsdale, AZ, by telephone on November 2, 2005. Firm initiated recall is complete.
Blood products, for which quality control testing was not performed, were distributed.
Platelets Pheresis Leukocytes Reduced. Recall # B-0437-12
Units: W038111350525; W038111350526 Part 1; W038111350526 Part 2; W038111350526 Part 3
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter on January 25, 2012 and January 31, 2012.
Manufacturer: Florida's Blood Centers, Inc., Leesburg, FL. Firm initiated recall is complete.
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0860-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0861-12
1) Unit: W067111706751;
2) Units: W067111706753; W067111706752; W067111703556
The Blood Center, New Orleans, LA, by telephone on October 4, 2011 and letter on October 26, 2011. Firm initiated recall is complete.
Blood products, which were labeled with the wrong product volume, were distributed.
Recovered Plasma. Recall # B-0864-12
CODE Unit: 011KY56348
American Red Cross Blood Services, Saint Louis, MO, by fax on November 19, 2011. Firm initiated recall is complete.
Plasma Frozen. Recall # B-0872-12
Red Blood Cells Leukocytes Reduced. Recall # B-0873-12
Unit: W038111376175
Florida's Blood Centers, Inc., Orlando, FL, by telephone on January 24, 2012. Firm initiated recall is complete.
Blood product, collected from a donor whose vital signs were not documented, was distributed.
1) Red Blood Cells Leukocytes Reduced. Recall # B-0897-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0899-12
1) Units: 29KL65328; 29GFL99595; 29GK81826; 29GY85608; 29KE88471; 29KE88805; 29FL99618; 29KL65331; 29KL65334; 29KL65338; 29KL65339; 29KL65449;
2) Units: 29KJ44194; 29KJ45360; 29KL63276; 29KL63280; 29KJ45367; 29KL63290; 29KL65331; 29KS17556; 29KS18565
Recovered Plasma. Recall # B-0909-12
Units: 2107577, 2107578, 2107579, 2107581, 2107582, 2107583, 2107586, 2107587, 2107886, 2107887, 2107888, 2107889, 2107890, 2107891, 2107892, 2107894, 2107895, 2107896, 2107897, 2107898, 2107899, 2107900, 2107901, 2107902, 2107903, 2107904, 2107906, 2107907, 2107909, 2107910, 2107911, 2107912, 2107913, 2107914, 2107915, 2107916, 6803363, 6803364, 6803365, 6803366, 6803367, 6803368, 6803369, 6803370, 6803371, 6803372, 6803373, 6803374, 6804625, 6804626, 6804627, 6804628, 6804631, 6804632, 6804634, 6804635, 6804636, 6804637, 6804638, 6804639, 6804640, 6804641, 6804642, 6808875, 6808876, 6808877, 6808878, 6808879, 6808880, 6808881, 6808882, 6808883, 6808884, 6808885, 6808886, 6808887, 6808889, 6808890, 6808891, 6808892, 6808893, 6808895, 6808896, 6808897, 6808898, 6808899, 6808900, 6809414, 6809416, 6809417, 6809418, 6809419, 6809420, 6809421, 6809422, 6809423, 6809424, 6809425, 6809426, 6809427, 6809428, 6809429, 6809431, 6812202, 6812203, 6812204, 6812205, 6812206, 6812207, 6812208, 6812210, 6812211, 6812212, 9129202, 9129203, 9129204, 9129205, 9129206, 9129207, 9129208, 9129209, 9129210, 9129211, 9129212, 9129213, 9129214, 9129215, 9129216, 9129217, 9129218, 9129219, 9129220, 9129221, 9129222, 9129223, 9129225, 9129226, 9129227, 9129228, 9129229, 9129230, 9129231, 9129232, 9129233, 9129234, 9129235, 9129236, 9129238, 9129239, 9129240, 9129241, 9129242, 9129243, 9129322, 94149035
AK, CA, CO, FL, KS, IL, MO, NJ, NY, TN, and Switzerland PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0920-12
Unit: 84W94042
The American National Red Cross, Oakland, CA, by telephone on February 27, 2008 and by facsimile on March 4, 2008. Firm initiated recall is complete.
1) Red Blood Cells Leukocytes Reduced. Recall # B-0925-12;
2) Recovered Plasma. Recall # B-0926-12
1) and 2) Unit: 6273061
Florida's Blood Centers, Inc., Orlando, FL, by letter dated September 23, 2008 or by e-mail on September 23, 2008. Firm initiated recall is complete.
Blood products, collected from a donor who was taking the medication Enbrel, were distributed.
FL, Austria
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
1) NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe. Recall # Z-0799-2012;
2) Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe. Recall # Z-0800-2012;
3) Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F. Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe. Recall # Z-0801-2012
1) Software v 5.60.2-5.71.4;
2) Units: CS09350168 CS-09140115 CS-09140135 CS-09140114 CS09160139 CS-09160155 CS-09070102R CS-09350179 CS-09350177 CS-09160147 CS-09160113 CS09140119 CS0916148 CS09350165 CS09140132 CS-09140122 Unknown Unknown CS-09350173 CS-09160136 CS-09160153 CS09350181 CS09350183 CS-09070109 RA090266M CS-09350171 C64SSU100081-0 CS-09350172 CS09140128 CS-09350174 CS-09350170 CS-09140111 Unknown CS-09160152 Unknown Unknown CS-09160141 CS-09160144 Unknown Unknown CS-09140117 CS09140112 CS-09160158 CS-09160123 CS-09160137 CS-09160126 CS-09140127 CS09350164 CS09140125;
3) Units: C64SSU090058 C64SSUS100002-0 C64SSU090040 C64SSU090015 C64SSU090027 C64SSU090025 C64SSU090029 C64SSU100096-0 C64SSU090068 C64SSU090058 C64SSUS100001-0 C65SSU100074 C64SSU090053 C64SSU090011 C64SSU100086-0 C65SU090054 C64SSU100098-0 C64SSU090028-1 C64SSU090028 C64SSU090030 C64SSU090031 C64SSU090067-1 C64SSU100088-0 C64SSU100079 C54SSU090035 C64SSU090044 C64SSU100091-0 CS64SSU090049 C64SSU090064 C64SSU090045 C64SSU100076 C64SSU090062 C64SSU100099-0 & C64SSU100104-0 C64SSU100069 C64SSU090033 C64SSU100073 C64SSU100101-0 C64SSU100093-1 C64SSU100082-0 C64SSU090036 C64SSU090022 C64SSU090051-1 CS64SSU090049 C64SSU090038 C64SSU100097-1, C64SSU100105-0, C64SSU100110-0 C64SSU090048 C64SSU090055-1 C64SSU090066 C64SSU100100-0 C64SSU100081-0 C64SSU100084-0 C564SSU090061-1 C64SSU100107-0 C64SSU090057-1 C54SSU100087-0 CS09160157 CS-09350163 C64SSU100096-0
CareFusion 209 Inc., Middleton, WI, by letter dated October 5, 2011. Firm initiated recall is ongoing.
It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also, it has been determined that the stimulus cable connection in the Cortical Stimulator Control Unit and C64 SSU Amplifier have the potential to develop a short circuit.
1) Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only, Sterile EO, Nonpyrogenic. Model number #'s: 67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, 69322, 69324, 69328, 69331, 69424, 69428, 69431, 69528, 69531. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0807-2012;
2) Medtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134, 66236, 66238, 66240, 66136, 66140. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0808-2012;
3) Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae. Rx Only, Sterile EO, Non-pyrogenic. Model #'s 67512, 67514, 67516, 67518, 67520, 67522, 67524, 67526, 67528, 67530, 67532, 67534, 67636.67638, 67640, 67536, 67540. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0809-2012;
4) Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s 68112, 68114, 68116, 68118, 68120, 68122, 68124, 68126, 68128, 68130, 68132, 68134, 68136, 68138, 68140. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0810-2012;
5) Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model # 91037. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0811-2012;
6) Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116, CB66118, CB66120, CB66122, CB66124, CB66128, CB66130, CB66132, CB66134, CB66136, CB66140, CB66236, CB66240, CB67312, CB67314, CB67316, CB67318, CB67320, CB67512, CB67514, CB67516, CB67518, CB67520, CB67522, CB67524, CB67528, CB67530, CB67532, CB67534, CB67536, CB67540, CB67636, CB67640, CB68112, CB68114, CB68116, CB68118, CB68120, CB68122, CB68124, CB68126, CB68128, CB68130, CB68132, CB68134, CB68136, CB68138, CB68140, CB69312, CB69316, CB69320,CB69322, CB69324, CB69328, CB69331, CB69428. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0812-2012;
7) Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & DLP6N48R4. Medtronic Intercept Custom Tubing Pack with Trillium Biosurface, Sterilized Using Ethylene Oxide, , Model # TL4F71R1. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0813-2012;
8) Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model #'s C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409B, C390601C, C390601D, C390702A, C390802A, C390903A, C391001B, C391102F, C391104F, C391203A, C391203B, C392502A, C392503A, C410201D, C410407A, C410407B, C431601A, C391104B, C391104D, C390601E, C350103B, C490901B, S342603B. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0814-2012
1) Model # / Lot # 69431 67312 67314 67316 2009010377 2008110555 2008101197 200808C074 2009010733 2008110584 2008101198 2008110082 2009011144 2008110593 2008101199 2008110085 2009030545 2008110627 200810C087 2008110088 200903C053 2008110628 2008110326 2008110227 2009050720 2008110769 2008111018 2008110238 2009051020 2008110932 2008111019 2008110456 2009060260 2008111015 200811C088 2008110457 2009060955 2008111016 2008120221 2008110471 2009070017 2008111017 2008120393 2008111020 2009081561 2008111148 2008120655 2008111270 2009090939 2008111269 2008120946 2008120222 2009101695 2008120219 2008121120 2008120223 2009110293 2008120220 200812C091 2008120656 2010011405 2008120651 200812C235 2008120947 2010012934 2008120652 2009010204 2008121121 2010022294 2008120653 2009010205 2009010334 2010030396 2008120654 2009010332 2009011377 2010031095 2008120945 2009010333 2009020247 2010032967 200812C034 2009011124 2009020248 2010032968 2009010331 2009011375 2009020249 201003C057 2009010878 2009011376 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69531 69424 2010112029 2008110390 2010110778 2009011320 2010012936 2009011396 2009081562 2009011397 200906C121 2009030262 2009060261 200903C007 2008111033 2009040079 2008120965 2009040702 2008120412 2009050328 2011101296 2009051019 2011091878 2009110971 2011082666 2009120232 2011080115 2010012932 2011041155 2010092656 2011040330 2010101389 2011032567 2011060954;
2) Model # / Lot # 66112 66114 66116 66118 66120 2008110236 2008110237 2008120309 200810C094 200810C088 2008110935 2008120210 2008120640 2008110451 2008110267 2008120639 2008120908 2008120641 2008110937 2008120540 2009010197 2008121119 2008120642 2008120211 2008120643 2009010423 2009010026 2008120909 2008120746 2008120877 2009010867 2009010322 2008121003 2008120939 2009010084 2009011116 2009010868 200812C053 2008121075 2009010199 200901C051 200901C019 2009010198 200812C087 2009010324 200902C084 200901C062 2009010323 2009010887 2009011117 2009040059 2009020851 200901C070 2009011331 2009020240 2009040152 200902C070 2009020239 2009030482 2009020507 200904R099 2009040153 200902C028 2009040154 2009020635 2009051305 2009040660 200902C089 2009040662 2009040217 2009060236 2009050296 2009040973 2009040974 2009041168 200906C104 2009050640 2009041167 2009050298 2009050299 2009070459 200905C098 200904R100 2009060238 2009050985 200907R043 2009060458 2009050297 2009060238 2009060239 2009080324 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2008111009 2008120217 2010121006 2009100211 2009010085 2008111010 2008120648 2010121007 2009110954 2009010330 2008111011 2008120944 2011010047 200912C089 2009010876 2008111012 200812C062 2011010328 2010012823 2009011122 2008120214 2009010328 2011020952 2010020270 2009030771 2008120215 2009010874 201102C050 2010031043 2009031074 2008120216 2009011373 2011030504 2010041078 2009040671 2008120647 2009020833 2010080606 200904R070 2008120942 2009030484 2010101106 2009050647 2008120943 2009030770 2010120623 2009050993 2009010203 2009031073 2010121147 2009051341 2009010327 2009040061 201110R134 2009061235 2009010873 2009040317 2009071056 2009011121 2009040670 2009071384 2009011335 2009041171 200907R033 2009011336 2009050307 2009080480 2009020245 2009050308 2009081942 2009020637 2009050646 2009090678 2009030167 2009050991 2009091610 2009030181 2009051340 200909R043 2009030182 2009060244 2009100212 2009030483 2009060465 2009100551 2009030769 2009060937 2009101090 2009031072 200907R040 2009110262 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2010041079 2010062731 2010080967 2010081503 2010081688 2010101312 2010102215 2010110196 2010120637 2011051727 2011052057 201107R028 2011090265 201109C157;
3) Model # / Lot # 67512 67514 67516 67518 67520 2008120772 2008120764 2009010345 2011051400 2009010363 2009020928 2008120951 2009020657 2011051756 2009011014 200902C083 2009021206 2009030252 2011051991 2009011126 2009060940 2009040678 2009080996 201109C051 200901C098 2009070724 2009050310 2009101098 2011100296 2009030778 2009120921 200906C140 2009120922 2011100296 2009040979 2010012832 200907C100 2010012834 2009081545 2010012832 2009110266 201003C172 2009102294 2010022256 2010012833 2010071569 2009120020 2010081992 2010020287 201008C158 2009121491 2010092162 201003C174 2010092166 2010012907 2011010390 2010080882 2011021006 2010031058 201101C123 2010081016 2011030122 2010051219 2011030269 2010081842 2011040908 2010081240 201103C206 2010082373 2011050610 2010082375 2011051757 2011020786 2011051212 201009C127 2011021764 2011061006 2011010165 201102C150 201106C159 2011011198 2011030477 2011070129 201102C020 201103C062 2011080426 2011040442 2011080425 2011082100 2011050734 2011100955 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201110R121;
4) Model # / Lot # 68112 68114 68116 68118 68120 200810C211 2008101200 2008120907 200811C069 2008120073 2008120225 2008120308 2008121123 2008120196 2009010209 2009010348 2008120660 2009010417 2009010208 2009010850 2009010419 2008120910 2009040066 2009010349 2009011133 200902C029 2009061242 2009040685 2009011132 2009011239 2009041127 2009100221 2009041181 2009041182 2009020717 2009060944 2009110963 2009060249 2009050317 2009050710 2009071392 2010011384 200906C132 2009060486 2009060250 2009091618 2010041080 2009080496 2009081947 2009061502 2009110962 2010060595 2009080497 2009090205 2009080498 2009111482 2010060696 2009081549 2009100558 2009080999 2009120926 201008C106 200908C182 2009101686 200909R028 2009121495 2010091334 2009101104 2009120198 2009102295 2010012899 2010100685 2009120197 2010010299 2009121497 201001C063 2010101102 2009121496 201003C060 2010011385 2010050411 2010110010 2010012054 2010060923 201001C006 2010051060 2010110015 2010071304 2010070386 2010031064 2010070728 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5) Model # / Lot # 91037 2008120758 2008121114 2009020137 2009040853 2009050547 2009061436 2010051435 2010101499 2011011022 2011030416 2011041113;
6) Model # / Lot # CB66112 CB66114 CB66116 CB66118 CB66120 CB66122 11813252 11843724 11827750 11843725 11813258 11584816 11799778 11827756 11785647 11813251 11799807 11561410 11785661 11785648 11760072 11799779 11754233 11538323 11760079 11773439 11749844 11785671 11734973 11502622 11734945 11710255 11710254 11734970 11710271 11452595 11691759 11691748 11691757 11572754 11669004 11254883 11613172 11681293 11681289 11561406 11655514 11182280 11610933 11669018 11641156 11508900 11641162 11150759 11599805 11599798 11584819 11493477 11627324 11091693 11572780 11561382 11561388 11434967 11599813 10919617 11561378 11538310 11502627 11264460 11528295 10856277 11538313 11528250 11385846 11182276 11490554 10843209 11411017 11452576 11276282 11173236 11315471 10820591 11370812 11373266 11182290 11150770 11278706 10792650 11361018 11370804 11091678 11137730 11241600 10773248 11326455 11361014 11137732 11123865 11206047 10751519 11264468 11326456 11123882 11103220 11193432 10721043 11241591 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10278853 10820602 10792655 10487821 10664501 10269086 10773255 10783534 10479549 10621269 10261336 10751528 10773256 10426811 10621268 10255180 10535606 10751529 10420866 10613429 10215034 10494779 10729532 10318698 10542895 10194016 10460192 10699713 10312644 10535612 10330244 10683914 10289569 10521703 10322857 10674171 10232684 10460168 10318737 10664499 10194032 10420870 10289548 10652265 10403801 10269093 10621483 10395328 10263877 10593921 10370324 10215033 10569691 10360554 10175994 10552220 10354598 10175985 10521714 10318729 10503897 10261367 10494769 10232492 10460195 10443546 10318688 10318689 10310114 10289597 10269108 10261311 10232712 10176003 CB67534 CB67536 CB67540 CB67636 CB67640 CB68112 11691780 11799776 11384688 11584779 11813262 11154393 11627325 11599804 11538291 11799809 11137721 11584818 11315473 11349219 11785634 11080525 11572761 11193472 11298129 11732169 10992843 11538318 11041185 11123878 10960988 10751531 11425919 10820606 11103223 10203287 11338574 10683900 11080542 11276288 10542972 11069189 11114390 10494789 11058850 11069187 10460144 11041186 11050717 10435537 11028724 11050654 10945756 11041184 10843212 10980901 10683865 11016749 10674110 11007105 10569684 10945755 10542973 10856289 10536238 10843152 10514216 10832397 10496084 10820605 10773257 10751530 10738035 10691438 10683882 10621494 10552233 10542876 10514241 10503889 10487832 10479499 10435543 10420860 10318732 10261372 10224561 10203282 10176011 CB68114 CB68116 CB68118 CB68120 CB68122 CB68124 11508865 11813242 11691746 11254886 11773429 11813248 11484956 11734964 11584789 11080562 11721235 11799766 11091656 11655472 11528294 11058813 11655478 11721234 11050663 11502626 11338711 11050675 11627323 11641138 11041187 11058828 11193474 11007107 11584800 11613154 10751532 11050686 11058845 10992844 11561402 11584803 10691422 11041188 11050699 10960989 11254888 11452597 10664497 11028725 11016750 10621313 11193446 11370808 10232687 10751533 11007106 10613412 11150797 11058802 10683859 10919619 10487841 11091686 11050667 10318690 10820607 10443566 10856290 11016751 10261324 10613410 10426820 10820608 10970852 10243437 10318694 10400250 10792657 10960990 10289565 10397628 10773258 10945757 10175995 10318693 10691475 10820609 10297680 10683869 10792658 10278787 10664494 10773259 10269115 10621308 10569662 10613564 10593937 10569695 10542879 10494757 10479537 10287042 CB68126 CB68128 CB68130 CB68132 CB68134 CB68136 11827739 11827760 11681282 11827757 11785639 11813223 11773407 11749829 11484942 11760046 11773435 11641135 11613138 11773410 11218603 11773447 11710259 11502597 11540970 11721254 11150750 11754238 11655466 11373272 11540971 11681294 11075680 11734949 11641125 11326445 11502612 11613145 10960991 11710244 11411011 10992845 11206082 11254859 10843153 11669002 11114370 10992845 11108136 11254874 10820611 11655473 11103232 10992845 11058827 11231072 10751535 11641126 11028726 10960993 11050687 11206077 10691449 11528261 11007110 10843214 10913656 11114372 10487840 11241589 10970853 10843214 10552215 11058811 10460171 11231067 10843213 10843214 10503882 11050674 10397562 11123833 10832399 10843214 10487839 11007108 10390340 11007109 10806908 10820612 10460143 10856291 10380510 10960992 10751536 10792659 10269111 10820610 10318733 10901168 10558730 10773260 10176024 10806907 10176012 10878787 10542980 10751537 10751534 10856293 10514226 10552239 10503895 10832398 10479478 10526617 10487799 10664505 10452170 10521715 10479543 10652262 10435573 10487833 10460133 10631764 10176013 10435575 10443547 10613578 10420853 10395326 10602844 10339017 10390320 10577111 10318721 10380506 10569697 10278857 10318723 10514228 10224558 10261342 10487801 10175977 10255183 10435535 10186264 10420856 10397560 10380515 10330247 10339020 10322860 10310107 10278881 10269080 10261309 10218186 10218176 10168507 CB68138 CB68140 CB69312 CB69316 CB69320 CB69322 11827728 11547343 No lot Manf No lot Manf 11760075 11528256 11827753 11349213 11691777 11315457 10930779 10867471 11641160 11193464 10487797 10832400 11599810 11150783 10479472 10602831 11561407 10773261 10460369 10558731 11543093 10762630 10380507 10339014 11538321 10738036 10339011 10318691 11502623 10652277 10278783 11373282 10651921 10168502 11326470 10651860 11315462 10651858 11254882 10185497 11182275 11080563 11058844 11041189 10992846 10970854 10960994 10856294 10832401 10820613 10806909 10792661 10699714 10652270 10613409 10602834 10577096 10569655 10542868 CB69324 CB69328 CB69331 CB69428 10820614 11627332 11827735 11827729 11610931 11773404 11114402 10843215 11621107 11584777 11091706 11241603 11547344 10577076 10856298 11231096 11538288 10552201 11193467 11484933 10542861 10901169 11173265 11154376 10535597 11114381 11075678 10514262 10919620 11091671 10970856 11075725 10691434 10923638 11041191 10398312 11007111 10278845 10980890 10980883 10232689 10960995 11028727 10970855 10945758 11041190 10923639 10901170 11050659 10878788 10856296 11069171 10843154 10820615 11114395 10783535 10773263 11150794 10751540 10613550 11182285 10583504 10569681 11206048 10261375 10176027 11241628 11278697 11338690 11349218 11538298 11538300 11543085 11584782 10186265 10261371 10487806 10494775 10503892 10514227 10542903 10683889 10721070 10738037 10751539 10773262 10792662 10806910;
7) Model # / Lot # DLP6N48R3 DLP6N48R4 TL4F71R1 11241044 11465359 11799944 11755661 11713167 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607;
8) Model #/ Lot # C330201C C330201D C330201E C330206B C342603A C350103B 201778990 201333560 205081295 201308440 204054606 201551424 202046133 205309658 203601818 202303911 202640160 205320345 203954482 202632898 203901734 205382559 204022437 202749853 203988245 205405093 205295088 204702221 204083070 205430380 205341343 204140301 205382558 205009633 C350106A C390101D C390203D C390406C C390409B C390601C 203386584 201756864 201271206 201089120 201333454 201254615 204702226 201905232 201301780 201503223 201467644 201293772 204814118 202008866 201350933 201649278 202740140 201323302 201446358 201762036 202949628 201585473 201567009 202025197 203360831 201699263 201930998 202369699 203745171 201764741 202012666 202561642 204288932 201927157 202165777 203310174 204311077 201983847 202831965 203863206 204311078 202147109 203040326 203974731 204981269 202338794 203176693 204285949 204311100 202607179 203824089 204359270 205191686 203031085 203989352 204772228 204311101 203280877 204083184 204942619 204311102 204140178 205058667 205402352 204524639 205198592 205505532 204878946 205502765 204981273 205090466 205167834 205260796 205284044 205322751 205389438 C390601D C390601E C390702A C390802A C390903A C391001B 201978568 204506615 201514769 201254604 201412703 201424864 203458279 204524638 201669440 201581163 201716502 203721546 204774490 201893277 201777104 203958431 204918792 202102480 202045021 204030513 205135410 202276601 203217589 204186594 205204813 203293858 203435712 204314702 205314074 203722121 203647848 204444206 205327511 203844438 203814643 205397133 203955760 203909330 204133788 203988762 204334538 204080477 204399838 204136158 204437462 204236435 204567894 204319619 204828993 204404301 204952274 204480662 205127283 205050557 205199773 205114489 205284050 205225609 205322756 C391102F C391104B C391104D C391104F C391203A C391203B 201260397 202335015 202648288 203814113 201592267 202335015 201316863 202721406 203912313 201779099 202564471 201328866 202956306 203989351 202031340 202648288 201354079 203435354 204315229 202201301 202629850 201582137 204486509 202721406 201685303 204703505 202956306 201767640 204976133 203212352 201923860 205135962 203457797 202018139 205284041 203703579 202147111 205357458 203829112 202338090 205455476 203958091 202607450 204005429 202832635 204133662 202978994 204339276 203218293 204421636 203420717 204642948 203657578 204796134 203824092 204943321 203966968 205059363 204038746 205113433 204080534 204323903 204424421 204501914 204921866 205014886 205114486 205291411 205459133 205512599 203824093 C392502A C392503A C410201D C410407A C410407B C431601A 204821370 204821369 201249841 201428181 205113428 205357187 205217073 204916548 201278746 201436433 205287910 205217281 201334984 201715753 205397136 201454169 201892654 205470270 201585444 201971522 205507854 201685309 202496001 201767422 202604823 201936374 203142177 202212131 203434662 202596479 203451447 202657601 203800302 202753829 204070146 202942379 204288401 203218561 204399839 203531683 204437258 203784895 204548389 203863203 204695802 203977359 204921862 204039082 204129083 204179722 204368226 204452404 204563923 204942617 205050810 205122774 205244751 205307931 205354349 205407856 202212132 C490901B S342603B 201748829 204426525 202689619 203819553 205086432 205203567
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated December 2011.
Manufacturers: Medtronic Cardia Surgery Division Europe, Kerkrade, Netherlands;
Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to product failure during use in ventricular assist procedures, which are outside the indications for use.
1,232,914 units
1) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0863-2012;
2) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Tough and Tilt (TNT). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0864-2012;
3) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0865-2012;
4) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab Tough & Tilt (BTNT) Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0866-2012;
5) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC Platform Chair Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0867-2012
1) Serial numbers: 32357-0904, 33303-1205, 33911-1106, 34312-0107, 34769-0807, 35216-0308, 35314-0408, 35337-0508, 35836-0109, 35669-1008, 35716-1108, 35752-1208, 35764-1208, 35908-0209, 35244-0308, 35627-1008, 35832-0109, 36050-0409, 36744-0610, 36805-0710, 36839-0810, 36849-0810;
2) Serial numbers: 32071-0304, 32390-0904, 32394-0904, 32420-0904, 32492-1004, 32584-1204, 32777-0305, 32849-0405, 32903-0505, 32956-0705, 32989-0805, 33689-1206,32585-1204, 33139- 0905, 33749-0606, 33750-0606, 33966-0806, 34222-1106, 34187-1206, 34277-1206, 34752-0707, 35390-0508, 35613-0908, 35956-0309, 35980-0309, 36264-0909, 36423-1209, 36460-1209, and 36648-0310;
3) Serial number: 35435-0608;
4) Serial numbers: 32031-0504, 32280-0704, 34402-0207, 33383-01 06, 33304-1205, 33409-0106, 33436-0206, 33515-0306, 34712-0607, 35899-0209;
5) Serial numbers: 32541-1104, 32912-0605, 33018-0805, 33828-0806, 36626-0310, 36665-0310, and 36827-0810
Gunnell, Inc., Millington, MI, by letters dated November 1, 2011. Firm initiated recall is ongoing.
Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs with dynamic recline would not hold a firm position, or as described by users, the back support or canes were spongy.
69 devices
Nationwide and Australia and Canada
Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents. Recall # Z-0870-2012
Unit: K051476
Impact Instrumentation, Inc., West Caldwell, NJ, by letter dated November 3, 2011. Firm initiated recall is ongoing.
A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.
***REF 66800694***Qty 10***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound. Product Code Number: 66800694. Recall # Z-0875-2012
Lot numbers: 50512962, 50512969, 50512974, 50513087, 50514672, 50513073, 50513074, 50517647, 50516110, 50539644, 50539645, 50539646, 50539647, 50555348, 50555349, 50555351, 50539648, 50546339, 50546340, 50548244, 50548245, 50548246, 50548247 and 50548248
Recalling Firm: Smith & Nephew Inc., Saint Petersburg, FL, by letter dated December 14, 2010.
Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
Recall due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.
71,329 units
1) Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. Recall Z-0989-2012;
2) Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514 BEN3786-754 A1 BEN3784-532 BEN3786-763 A2 BEN3784-541 BEN3784-738 A3 BEN3784-550 BEN3784-747 A3.5 BEN3784-569 BEN3784-756 A4 BEN3784-578 BEN3784-765 B1 BEN3784-596 BEN3784-774 B2 BEN3784-603 BEN3784-783 C1 BEN3784-612 BEN3784-792 C2 BEN3784-621 BEN3784-809 C3 BEN3784-649 BEN3784-818 D2 BEN3784-722 BEN3784-818 Universal Opaque BEN3784-685 BEN3784-827 A0 BEN3784-701 BEN3784-836 Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. Recall # Z-0990-2012
Recalling Firm: Sybron Dental Specialties, Orange, CA, by letters dated April 20, 2011, November 10, 2011 and December 8, 2011.
Manufacturer: Kerr Corp., Orange, CA. Firm initiated recall is ongoing.
The Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude.
77,289 Units
Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography. Model Numbers DX-D 20G and DX-D 20C; Catalog Numbers ABC. Recall # Z-1062-2012
Code 5PYTM and 5PYUO
RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter dated January 16, 2012.
Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Firm initiated recall is complete.
The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot.
GE SENOGRAPHE 2000D Full Field Digital Mammography System (SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems. Recall # Z-1063-2012
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Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated October 17, 2011.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material. Recall # Z-1146-2012
Lot Number: 3510059
Recalling Firm: Sybron Dental Specialties, Orange, CA, by letters dated November 17, 2010.
Manufacturer: Kerr Corp., Orange, CA. Firm initiated recall is complete.
It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.
Nationwide, Canada and Pakistan
Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part individually packaged sterile, or as one (1) unit which is kitted within an instrumentation tray at which point, the product is non-sterile until the tray in which it is kitted is sterilized a the designated facility. The product is indicated for use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Model #295214S, Part #295214SND. Recall # Z-1147-2012
Batch #EGH9
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter on December 21, 2011.
Manufacturer: Newdeal Sas, Saint Priestsaint Priest, France. Firm initiated recall is ongoing.
Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.
Nationwide, United Kingdom, France, Switzerland, and Austria
1) Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. Recall # Z-1196-2012;
2) Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. Recall # Z-1197-2012
1) Software Version R4.1.x S/N: 284 290 291 293 294 295 296 297 298 299 303 305 306 307 308 309 310 312 314 315 316 317 318 327 329 338 346 349 350 352 353 354 354 355 358 362 365 366 367;
2) Software Version R4.1.x S/N: 3 5 6 8 9 10 12 13 14 15 16 17 18 19 22 23 24 25 26 27 28 29 30 32 33 34 36 37 38 39 40 41 46 47 50 51 52 53 54 55 56 58 60 61 63 64 65 66 67 68 69 70 71 72 73 75 76 77 78 79 80 81 82 83 84 85 88 93 94 95 96 97 98 100 101 103 104 105 106 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 125 126 129 130 131 132 133 134 135 136 137 138 142 143 144 146 147 148 149 151 152 155 157 159 160 161 162 167 168 170 174 175 176 177 179 180 181 182 185 186 187 189 190 191 193 194 195 196 197 201 202 204 205 206 207 208 209 210 211 213 216 217 219 220 221 222 223 224 225 228 233 234 235 237 240 241 242 244 246 247 249 251 253 254 255 257 259 261 262 264 265 266 268 269 272 273 277 278
Philips Medical Systems Nederlands, Best, Netherlands, by letter dated February 21, 2012. Firm initiated recall is ongoing.
Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
1) 39; 2) 192
1) Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient. Recall # Z-1199-2012;
2) Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient. Recall # Z-1200-2012
CODE 1) and 2) All lots of the components are recalled. Serial numbers: H600097 H600254 H600255 H600268 H600274 H600341 H600345 H600352 H600377 H600381 H600416 H600435 H600437 H600462 H600513 H600524 H600538 H600546 H600548 H600583;
Recalling Firm: Varian Medical Systems, Inc., Charlottesville, VA, by letter dated January 5, 2012.
Manufacturer: Varian Medical Systems Haan, Haan, Germany. Firm initiated recall is ongoing.
Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
Nationwide and Canada, Japan and Sweden
da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Recall # Z-1202-2012
IS2000 and IS3000, serial numbers: USG484 USG364 SH1071 SH0569 SH0508 SH0449 SH0412 SH0063 SG489 SG204 SG2013 SG2006 SG804 SG108 SG150 SG734 SH0411 SH0209 SH0329 SH0148 SG326 SG794 SH0511 SH1102 SH0991 SH0882 SH0881 SH0878 SH0758 SH0757 SH0573 SH0570 SH0568 SH0567 SG675 SG176 SH0210 SH0364 USG071 SG498 SG095 SG070 SG735 SG076 SG779 SH0817 SH0461 SG597 SG306 SH0636 SH0190 SG411 SH0475 SH0915 SH0234 USG043 SG2024 SH0564 USG754 SH0841 SG572 SG830 SG812 SG369 SG2018 SG834 SH0653 SH0086 SH0957 SH0659 SH0406 SH0249 SG031 SH0258 SG035 SG608 SH0293 SH0280 SH0334 SG447 SH0430 SH1129 SG448 SH0275 SG280 SH0681 SG302 SG327 SG325 SG086 SG291 SG614 SG129 SG626 SG417 SG104 SH0229 SG106 SH0227 SG105 SH0228 SH1029 SG655 SG653 SH0772 SH0092 SH0750 SG088 SH0594 SH0154 SG235 USG508 SG785 SH0501 SH0079 SH0202 SH0730 SH0977 SH0110 SH0651 SH0942 SH0933 USG026 SH0932 SG188 USG132 SG534 SG595 SG276 SH0180 SG193 SG842 SH1123 SH1003 SG412 SG180 SH0478 SH0513 SH0862 SG318 SH0109 SH0642 SG565 SG197 SH0640 SH0399 SG611 SH0872 SH0175 SG2001 SG211 SH0315 SH0678 SH0993 SG184 SH1086 SG143 USG515 SG662 SH0619 SH0696 SH0768 SH0767 SH1145 SH0247 SH0711 SH0779 SH0536 SH0361 SG883 SG820 SG816 SG757 SG738 SG665 SG467 SG435 SG349 SG290 SG2008 SG159 SG667 SH0285 SG284 SH0663 SG362 SG825 SG776 SG714 SG827 SG875 SG838 SG258 SG740 SH0271 SG308 SG839 SG383 SG465 SH0093 SG259 SG257 SG537 SH1093 SH0423 SH0491 SG781 SH0121 SH0751 SG100 SG588 SG768 SH1124 SG533 SG548 SH0997 SH0897 SG2033 SG706 SG466 SG2041 SG138 SG419 SH0410 SH0884 SG382 SH0811 SG739 SH0497 SH0858 SG674 SH0701 SH0986 SG055 SH0967 SH0670 SH0669 SH0355 SH0610 SG564 SG387 SG632 SH0431 SH1081 SH0493 SH0473 SH0755 SH0729 SH0673 SH0722 SH1018 SH1091 SH0419 SG612 SH1026 SG422 SH0450 SH0089 SG200 SH1068 SH0592 SH0591 SH0141 SH0794 SG2028 SG107 SH0087 SH1103 SG160 SH0213 SG553 SH0452 SH0928 SG222 SH0705 SG621 SH0896 SH0042 SH1143 SG561 SG697 SH0173 SH0291 SG540 SG758 SH0987 SH0072 SH0693 SG766 SG026 SG075 SG682 SG831 SG130 SG809 SG813 SG805 SG671 SH0820 SG335 SG005 SG808 SG252 SG829 SH0965 SG815 SG814 SH0067 SG578 SG423 SH0892 SH0886 SG322 SG303 SG399 SH1097 SH1004 SG087 SG2020 SH1005 SH0522 SG357 SG374 SH0193 SH0372 SG677 SG398 SG716 SG260 SH1036 SH0127 SH0019 SG328 SG320 SG207 SG233 SG232 SH0778 SH0200 SH0199 SH0198 SH0197 SH0196 SG275 SG2022 SG008 SG438 SG368 SG733 SG678 SG708 SH0832 SG795 SH1114 SH0833 SH0680 SG640 SG679 SG347 SG370 SH0296 SG596 SH1070 SH0454 SH1106 SH0801 SH0800 SH0799 SH0297 SH0272 SH0810 SH0345 SG645 SH0585 SG503 SH0308 SG077 SG619 SG270 SG265 SH0177 SH0054 SH0733 SH0665 SH0658 SH0574 SH0534 SH0357 SH0328 SH0251 SH0062 SG823 SG742 SG452 SG425 SH0893 SH0598 SH1069 SG725 SH1017 SG520 SH0332 USG113 SG566 SG835 SH0714 SG762 USG703 SG551 SG2009 SG2015 SG189 SH0962 SG605 SH0474 SG582 SG481 SH0980 SH0088 SH0528 SH0743 SH1031 SH0443 SG2037 SH0654 SG2035 SG2004 USG642 USG332 SH0698 SH0689 SH0690 SH0688 SG661 SG2030 SH0910 SH0909 SG116 SH0218 SG166 SH0921 SH0798 SG255 SG436 SH0555 SH0116 SH0816 SG495 SG652 SH0126 SG434 SG472 SG122 SH0609 SH1013 SG2029 SH0737 SG194 SH0641 SG643 SH0964 SH0309 SH1076 SG636 SH0113 USG213 SH0115 SH0356 SG514 SH1059 SH0704 SH0727 SH0898 SG429 SH0025 SH0048 SG752 SH0869 SG033 SH0927 SH0181 SH1134 SH0349 SG575 SG301 SG523 SG524 SH0516 SG641 SH0256 SG299 SG437 SH0668 USG230 SH1052 SH0279 SH0278 SH0052 SH0051 SG373 SG371 SG2034 SG048 SH0624 SH0499 SH0498 SH0049 SG054 SH0956 SH1149 USG728 SG771 SH0333 SG027 SH0440 SH0165 SH0702 SG500 SH0904 SH0903 SG307 SG078 SG269 SG2025 SH0890 SG492 SH0835 SG672 SG724 SH1148 SH1136 SG623 SH0853 SH0793 SH0224 USG146 SH1132 SH0638 SH0515 SH0417 SH0354 SH0036 SG144 SG660 SH1138 SG822 SH1014 SH0082 SH0547 SG283 SG507 SH0529 SH0445 SH0490 SG112 SH0813 SH0167 SH0565 SG406 SH0740 SG841 SG505 SG689 SG819 SG530 SG664 SG378 SG377 SG366 USG317 SH0103 SH0099 SG177 SH0985 SH0058 SH0885 SG765 SH0868 SH0353 SG456 SG457 SH0390 SG573 SH0527 SH0526 SH0018 SG658 SG162 SG149 SG051 SH0712 SH0432 SH0946 SH0906 SH0721 SG2031 USG727 SH0759 SH0339 SG562 SH0531 SG351 SG169 SG555 SG554 SH1001 SH0463 SH0608 SG584 SG400 SG123 SH0174 SH0976 SG461 SH0796 SH0633 SH1092 SG699 SG271 SG272 SH0560 SH0781 SH0780 SH0521 SG618 SG237 SH0622 SG427 USG201 USG044 SH0035 SH0703 SH0055 SG254 SH0192 SH0556 SH0971 SH0301 SG432 SG073 SH0647 SH0489 SH1041 SH0859 SH0404 SH1057 SG288 SH0352 SH0468 SG755 SG476 SG471 SG300 SG571 SG350 SH1061 SH1108 USG806 SH1073 SH1028 SG199 SH1064 SH1088 SG844 SG828 SH0589 SH1153 SH1083 SH0546 SG267 SH1042 USG800 SH1012 SH1011 USG802 SH0477 SH0045 SH0671 SH0426 SG167 SG360 SH0613 SH0694 SG760 SG2027 SG798 SG710 SH0988 SG544 SG021 SH0948 SG628 SH0723 SH0683 SH0697 SH1023 SH0214 SG485 SG131 SH0551 SH0169 SH0168 SH0171 SG091 USG775 SH0789 SH0170 SG263 SH0085 SH0273 SH0205 SH0398 SG292 SG246 SH0504 SH0123 SG528 SH1090 SH0639 SG480 SH0880 SH1062 SH1113 SG430 SH0350 SH0939 SH0012 SG372 SH0186 SH0655 SH0013 SH0827 SG521 SG068 SH0699 SH0995 SG179 SH1019 SG736 SG482 SH0505 SG415 SH0156 SG450 SG901 SG897 SG878 SG895 SG884 SG888 SG2023 SG899 SG862 SG886 SG896 SG863 SG900 SG850 SG893 SG892 SG874 SG887 SG894 SG877 SG885 SG889 SG898 SG052 SH0805 SH0584 USG748 USG750 SG224 SG223 SH0646 SH0429 SH0139 SH0138 SG003 SG891 SG861 SG860 SG859 SG858 SG857 SG856 SG855 SG854 SG853 SG852 SG851 SG849 SG848 SG558 SG547 SH0996 SH0754 SH0464 SH0307 SG531 SH1152 SH0060 SG281 SH0761 SG676 SH0317 USG726 SH0488 SH0403 SG761 SG591 SH0201 SG024 SG579 SH1079 SG196 SH1047 SH0593 SH0562 SG379 SG081 SG711 SH0028 SG346 SG2039 USG577 SG483 SH0958 SH0561 SH0084 SG753 SG478 SH0828 SH0377 SG666 SG833 SH0870 SG315 SG047 SG2005 SH0422 SH0421 SG173 SG2032 SG638 SH0629 SH0628 SH0774 SG253 SH1051 SH1050 SG426 SG407 SH1060 SH0919 SH0476 SH0096 SH0300 SH0232 SH1115 SH0715 USG788 SH0582 SG464 SH0250 SH0935 SH0864 SH1080 SG083 SH0625 SG746 SH0687 SG096 SH0648 SG312 SH0483 SH1085 SH0618 SG440 SH0905 SH0203 SG049 SH0825 SH0766 SH0819 SG602 USG700 USG631 SH0940 SH0923 SG745 USG147 SG585 SH0635 SH0056 SH0466 SG723 SG140 SG620 SG363 SH0902 SG339 SH0111 SH0691 SG183 SH0360 SG355 SG593 SG185 SG418 SH0220 SG793 SH0216 SH0215 SH0925 SH0912 SH0559 SH0558 SH0575 SH0206 SH0615 SH0614 SH0185 SH0572 USG552 SH0731 SH0535 SG792 SG698 SH0760 SG509 SG310 SG174 SH0874 SG297 SH0321 SH1002 SH0792 SG409 SH0550 SH0397 SH0456 SG198 SH0839 SH0821 SH0782 SH0749 SH0748 SH0129 SG215 SG161 USG770 SH0804 SH0786 SH0685 SH0557 SH0441 SH0344 SH0343 SH0342 SH0207 SG234 SH0934 SH0040 SH1055 SH1054 SH0577 SH0576 SH0152 271326 SH1022 SH0163 SH0374 SH0033 SG783 SH0979 SG333 SG2011 SH0020 SH0963 SH0532 SH1130 SH1032 SH0847 SH0806 SH0732 SG778 SG763 SG615 SG490 SG441 SG244 SG433 SH0617 SG470 SG644 SH0437 USG559 SH0777 SH0385 SH0306 SH0069 SG569 SG293 USG015 SH1151 SG444 SG039 SH0599 SH0140 SH0137 SG341 SG2026 SH0135 SG737 SG148 SH0348 SH1077 SH0643 SH1128 SG413 SH0068 SH0601 SH0204 SG696 SG609 SH0848 SH0717 SH0634 SH0183 SH0189 SH0265 SG486 SG345 253342 SH1104 SH1095 SH0645 SH0370 SH0260 SG570 SG431 SG359 SG268 SG242 SG120 SH0838 USG101 SH0184 SG463 SH1094 SG580 SH0597 SG603 SG182 SH0973 SH0972 SH0974 SH0900 SG060 SH0241 SH0580 SH0029 SH0151 SH0030 USG018 SG380 SH0552 SH0982 SG556 SH1087 SG145 SG549 SG439 SH0837 SH0230 SG497 SH0544 SH0953 SH0325 SH0057 SG473 SH0840 SH0376 SG458 SG334 SH0713 SH0153 SG890 SH0907 SH0736 SG659 SH1139 SG568 SG499 SH1040 SH0644 SH0401 SH0021 SG693 SG396 SH0242 SH0448 SH0286 SG020 SH0563 SG468 SH1027 SH0319 SG451 SG586 SH0438 SH0100 SH0954 SH0073 SH0590 SG2021 SG041 USG136 SG589 SH0632 SH0773 SH0649 SH0851 SG225 SH0253 SH0335 SH0842 SG607 SG195 SG474 SH0951 SH0950 SH0949 SH0166 SH0022 SG538 SG2017 SG191 SH0795 SH0586 SG319 SH0346 SH0439 SH0338 SH0337 SG128 SG289 SH0402 SH0041 SG542 USG642 USG577 USG515 USG136 SH1116 SH1100 SH1099 SH1055 SH1038 SH1001 SH0781 SH0578 SH0239 SG017 SH0814 USG773 USG125 SH1135 SH0428 SG139 SH0427 SH0975 SH0024 SH0108 SG790 SG557 SG036 USG701 SG261 SG2003 SH0442 SH0554 SH1133 SH0899 USG217 SH0631 SH0034 SG192 SH0695 SH0112 SH0026 SH0415 SH0414 SH0457 SH0549 SH0065 SH0420 SG262 SH0785 SH0947 SH0876 SH0510 SH0031 SG629 SG093 SH0368 SH0261 SH1067 SH0150 SH0455 SH0081 SG210 SG2045 SG502 SH0467 SG324 SH0434 SG526 SG212 SG080 SH0238 SG840 SG796 SG581 SG2012 SH0320 SG361 SG744 SG797 SG219 SH0545 SH0095 SG236 SH0465 SG245 SG475 SH0125 SG627 SH0887 SG598 SH0459 SH0413 SH0929 SH0495 SH0791 USG443 SG2040 SH0299 SG278 SH0118 SH0856 SG050 SG868 SH0931 SH0351 SH0124 SH0386 SH0834 SH0494 SH0188 SH1116 SH0187 SH0764 SH0765 SH0753 SG719 SH0131 SG117 SG606 SH0252 SG249 SG550 SH0845 SG408 SH0607 SH1075 SH0692 SG158 SH0990 SH1110 SH0707 SH1084 SH1056 SH0471 SG536 SH0223 USG062 SG401 SG098 SH1101 SH0961 SH0857 SH0742 SH0600 SH0147 SH0146 SH0145 SH0032 SH0268 SH0191 SH0875 SG410 USG053 SH1140 SH0861 SH0257 SG650 SG304 SG206 SH0157 SG683 SG202 SG019 SH0132 SG657 SH1038 SH1072 SH0143 SH1048 SG479 SG152 SH0871 SH0983 SH0739 SG695 SG205 SH0259 SG163 SH0908 SG2014 SH0803 USG721 SH1118 SG712 SG390 SH1066 USG764 SG305 SG803 SG264 SH0627 SG670 SG164 SH0844 SH0496 SH0756 SH0433 SG720 SG709 SH0815 SH1010 SH0506 SH0469 SH0581 SG391 SG691 SG385 SG119 SH0119 SG424 SH0596 SH0425 SH1096 SG477 SH0312 SG759 SG663 SH0679 SG807 SH0676 SH0675 SG178 SH0917 SH0451 SH0588 SH0134 SH0046 SG127 SG040 SG028 SG651 SH0380 SH0650 SH0807 SG510 SG337 SH0097 SG656 SH0133 SH0930 SH0891 SG442 SH0130 SG449 SG099 SH0270 SH0706 SG356 SG030 SG181 SH0866 SH0941 USG718 USG713 USG172 SH0822 SH0039 SH0818 SH0038 SH0852 SG493 SG491 SH0282 SH0064 SG647 SH0708 SH0823 SG625 USG151 SH0194 SH0709 SH0267 SG567 USG769 SH0266 SH0922 SH0149 SG780 SG344 SG336 SH0657 SG238 SH0217 SH0966 SH0383 SH0098 SG529 SH1074 SH0955 SH0393 SG488 SH0362 SH0323 SG216 SG038 SG014 SG157 SG843 SH0926 SH0162 SH0161 SG395 SG381 SH0620 SH0359 SG2038 SH0037 SG376 SH0700 SH0602 SH0503 SH0502 SH0078 SH0076 SH0274 SH0424 SH0936 SH0999 SH0179 SG624 SG496 SG494 SH1111 SG059 SH0776 SH1147 SG348 SH1037 SH1033 SH0240 SG022 SG563 SG799 SH0164 SH0867 SH0616 SH0486 SH0981 SH0292 SH0462 USG029 SH0746 SH0745 SG673 SG688 SH1137 SH0674 SH0409 SH0318 SH0883 SH0212 SH1034 SH0970 SG654 SG250 SG2007 SG2002 SG118 SH0378 SH1009 SH0994 SH0992 SH0863 SH0860 SH0595 SH0053 SG121 SH0288 SH1000 SH0514 SH1030 SH0485 SH0044 SH0518 SH0517 SG782 SH1144 SH1109 SH0763 SG637 SH1065 SH0989 SH0626 SH0612 SH0533 SH0519 SH0363 SG239 SG2010 SG065 SH0830 SH0829 SH0808 SG311 SH1058 SH0379 SH0246 SG574 SG2016 USG342 SH0938 SH0937 SH0790 SH0284 SH0136 SG546 SG404 SG342 SG175 SG013 SH0873 USG622 SH0104 SH0373 SH0290 SH0281 SH0254 SG403 SG397 SH0623 SH0102 SH0101 SG227 SG687 SG393 SH0716 SH0396 SG722 SG705 SG340 SH1127 SH1125 SG460 SG446 SG634 SH0479 SG576 SH0408 SH0233 SH0826 SG587 SG155 SH1053 SG613 SG386 SH1131 SH0762 SH0248 SH0231 USG082 SH1078 SH0400 SH0289 SG511 SG094 SG680 SH0984 SH0879 SG717 SH0741 SH0418 SG285 SG279 SH0901 SH1119 SH0662 SH0276 SG133 SG011 SH0211 SG543 SG535 SG601 SG247 SG142 SH0405 SH0395 SH0283 SG314 SG186 SG539 SG751 SH1043 SG648 SG832 SH1045 SG487 SG811 SH0061 SG743 SG669 SG729 SG298 SG741 SG583 SH0071 SH0195 SG756 SG273 SH1044 SH1105 SG633 SH0245 SG694 SH0725 SG103 SH0783 SG668 SH0330 SH0331 SH0324 SH0172 USG353 SH1008 SH1007 SH1006 SH0775 SH0460 SH0047 SG287 SG218 SH0682 SH0784 SG462 SH0263 SH0262 SG518 SH0849 USG331 SH0831 SG686 SH0630 SG063 SH0484 SG214 SG316 SH0543 SH0160 SG681 SH0298 SG309 SH0611 SH0487 SG367 SG058 SH0583 SH0340 SH0225 SH1039 SG321 SH0416 SG826 SH0894 SH0316 SG616 SH1089 SG707 SH0305 SH0843 SH1120 SH0530 SG012 SG504 SG731 SG324 SH0387 SG685 SH0066 SH0960 SH0391 SH1126 SH0235 SH0525 SH0482 SG208 SG821 SH0369 SG747 SH0458 SG170 SG165 SH0384 SG042 SG453 SH0208 SG241 SH1121 SH1063 SH0738 SH0367 SH0178 SH1035 SH0500 SG090 SH0277 SH1016 SH0945 SH0718 SG545 SH0389 SH0566 SG354 SH0719 SG251 SH0388 SH0809 SG067 SH0553 SH0998 SH0637 SH0155 SH0091 SH0077 SG522 SG454 SG009 SH0221 SH1015 SG594 SH0769 SH0094 SG527 USG517 USG156 USG072 SH1150 SH1142 SH1100 SH1099 SH1082 SH1025 SH0918 SH0914 SH0877 SH0855 SH0672 SH0621 SH0587 SH0571 SH0436 SH0435 SH0407 SH0382 SH0347 SH0311 SH0310 SH0304 SH0303 SH0302 SH0294 SH0255 SH0226 SH0182 SH0159 SH0158 SH0105 SH0080 SH0070 SH0059 SG420 SG329 SG296 SG295 SG294 SG231 SG2042 SG187 SG111 SG110 SG109 SG089 SC0005 SH1107 SG229 SH0735 SH0734 SG630 SH0523 SH0142 SH0392 SH0524 SH0394 SG153 SH0667 SH0090 SH0802 SG824 SG818 SH0117 SH0492 SG789 SH0520 SH0507 SH0381 SH0336 SG749 SG704 SG692 SG323 SG102 SG092 SH0371 SG599 SG532 SH0222 SG639 USG787 SH0606 SH0605 SH0604 SH0144 SG428 SG032 SH0295 SG358 SH1141 SG2019 SH0969 SH0968 SH0812 SG881 SG836 SH0447 SG046 SH0114 SH0664 SG837 SH1122 SH0579 SH1112 SH0375 SG286 SH0846 SH0924 SG455 SG516 SG037 USG786 SH0752 SH0107 SH0836 SG810 SG137 SH0050 SH0472 SG767 SG330 SH0219 SG034 SG784 USG240 SH0824 SH0677 SG061 USG352 SH0128 SG772 SH0512 SH0313 SH0314 SH0176 SH0686 SH1024 SH0889 SH0481 SH0480 SH0865 SH0684 USG702 SH0770 SH0920 SH0548 SG525 SG375 SG590 SG190 SG560 SG392 SG025 SG084 SG506 SG617 SH0747 SH0744 SH0358 SG732 SH1098 SH0656 SH0120 SG282 USG445 SH0453 SH0470 SH0854 SH0895 SH0106 SH0850 SG343 SH0243 SG313 SH0913 SH0726 SH0578 SG057 SH1146 SH0710 SH0509 SG168 SG684 SG801 SH0724 SH0327 SH0326 SG541 SG2036
Intuitive Surgical, Inc., Sunnyvale, CA, by letter dated February 3, 2012. Firm initiated recall is ongoing.
The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions.
1,996 total units
1) Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; tray catalog number 4420 The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions. Recall # Z-1207-2012;
2) Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; tray catalog number 4468 The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions. Recall # Z-1208-2012;
3) Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; tray catalog number 4469A The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and
1) Lot numbers: 0000319389, 0000321446, 0000323733, 0000326090, 0000328468, 0000330882, 0000333747, 0000336418, 0000336443, 0000340606, 0000344792, 0000349464, 0000354078, 0000354079, 0000358785, 0000367470, Y11Cl711, Y11C2202, Y11C3733, Y11C3751, Y11D0544;
2) Lot numbers: 0000310407, 0000310409, 0000310411, 0000310413, 0000312077, 0000312080, 0000312081, 0000313225, 0000313227, 0000313229, 0000313233, 0000313523, 0000314761, 0000314762, 0000315476, 0000315477, 0000315478, 0000315480, 0000317227, 0000317229, 0000317230, 0000317231, 0000318349, 0000318350, 0000318351, 0000318352, 0000319401, 0000319402, 0000319403, 0000319404, 0000319405, 0000321997, 0000321998, 0000321999, 0000322000, 0000322001, 0000323739, 0000323740, 0000323741, 0000326095, 0000326097, 0000326099, 0000326100, 0000326101, 0000326103, 0000326104, 0000328472, 0000328473, 0000328474, 0000328475, 0000328497, 0000328502, 0000328504, 0000330880, 0000330881, 0000330884, 0000330885, 0000330886, 0000333712, 0000333754, 0000333755, 0000333756, 0000333757, 0000333758, 0000333759, 0000333761, 0000333762, 0000336431, 0000336433, 0000336434, 0000336435, 0000336437, 0000336439, 0000336442, 0000336448, 0000336449, 0000336450, 0000336451, 0000336452, 0000336453, 0000342781, 0000342782, 0000342783, 0000342785, 0000342786, 0000342787, 0000342788, 0000342789, 0000342790, 0000344054, 0000344798, 0000344800, 0000344810, 0000344811, 0000344812, 0000347086, 0000347087, 0000347088, 0000347090, 0000347091, 0000347093, 0000347094, 0000347095, 0000347096, 0000349465, 0000349466, 0000349467, 0000349473, 0000349812, 0000351290, 0000351684, 0000351687, 0000354085, 0000354087, 0000354089, 0000354091, 0000354096, 0000354100, 0000356292, 0000356294, 0000356296, 0000356299, 0000356300, 0000361254, 0000361255, 0000361284, 0000615475, Y1051567, Y10S2362, Y10S2363, Y10S2370, Y10S2371, Y10S2372, Y10S2402, Y10S2436, Y10S2988, Y10S2989, Y10S2990, Y10S3008, Y10S3011, Y1053012, Y10S3118, Y10S3119, Y11A0340, Y11A0341, Y11A0347, Y11A0349, Y11A1125, Y11A1139, Y11A1147, Y11A1148, Y11A1155, Y11A1270, Y11A1980, Y11A1981, Y11A1982, Y11A2013, Y11A2014, Y11A2637, Y11A2638, Y11A2639, Y11A2729, Y11A2733, Y11A2734, Y11A3238, Y11A3239, Y11A3240, Y11B0276, Y11B0279, Y11B0290, Y11B0411, Y11B0603, Y11B0949, Y11B0959, Y11B0960, Y11B0961, Y11B1240, Y11B1241, Y11B1427, Y11B1651, Y11B2564, Y11B2566, Y11B2925, Y11B2927, Y11B2928, Y11B2932, Y11C0274, Y11C0275, Y11C0283, Y11C0284, Y11C0318, Y11C0319, Y11C0320, Y11C1275, Y11C1276, Y11C1277, Y11C1278, Y11C1280, Y11C1976, Y11C1977, Y11C2146, Y11C2147, Y11C2865, Y11C3085, Y11C3086, Y11C3103, Y11C3104, Y11C3105, Y11C3141, Y11C3142, Y11C3744, Y11C3745, Y11C3746, Y11C3752, Y11D0541, Y11D0542, Y11D0777, Y11D0778, Y11D0783, Y11D0784, Y11D0785, Y11D0786, Y11D0787;
3) Lot numbers: 0000312078, 0000312079, 0000313237, 0000315474, 0000317224, 0000317225, 0000317226, 0000319388, 0000319398, 0000319399, 0000319400, 0000321995, 0000326091, 0000330888, 0000331259, 0000331933, 0000333748, 0000333749, 0000333750, 0000336430, 0000336454, 0000340623, 0000342778, 0000342779, 0000342780, 0000344796, 0000347085, 0000348120, 0000351690, 0000354083, 0000356290, 0000361072, Y10S1161, Y10S1568, Y10S2006, Y10S2007, Y10S2364, Y10S2993, Y11A1149, Y11A2470, Y11A3023, Y11B0434, Y11B0955, Y11B1613, Y11B2924, Y11C0276, Y11C1279, Y11C1855, Y11C3087, Y11D0543, Y11D0779
Recalling Firm: Carefusion 2200 Inc., McGaw Park, IL, by e-mail dated February 7, 2012.
Manufacturer: CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V, Mexicali.B.C., Mexico. Firm initiated recall is ongoing.
for washing lacerations and abrasions. Recall # Z-1209-2012
The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution, which may represent a patient safety hazard.
1,644,150 trays
1) MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. With the optional drop section, the use expands to echo/stress echo/Doppler studies, and vascular and carotid echo. Recall # Z-1210-2012;
2) MPI Rapid Response HUT Table, Model #RRHUT 1017. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. Recall # Z-1211-2012
1) Serial numbers: 802286, 802303, 802782, and 802722;
2) Serial numbers: 802421, 802780, 802781 802783, and 802784
Medical Positioning Inc., Kansas City, MO, by letter dated March 5, 2012. Firm initiated recall is ongoing.
The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "OFF" position prior to connecting the unit to electric power.
SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. Device Codes: a) S-04-120-120-G3; b) S-04-040-120-G3; c) S-04-060-120-G3; d) S-05-040-120-G3; e) S-05-060-120-G3; f) S-05-080-120-G3; g) S-05-100-120-G3; and h) S-06-080-120-G3. Recall # Z-1213-2012
a) Lot Number 05180062; b) Lot Numbers 05180031; c) Lot Number 05187032; d) Lot Number 05180034; e) Lot Number 05180035; f) Lot Number 05180036; g) Lot Number 05180037; and h) Lot Number 05180042
IDEV Technologies, Inc., Webster, TX, by letter dated February 15, 2012. Firm initiated recall is ongoing.
The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).
Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids. a) Elecsys 2010 Analyzer Rack; b) Elecsys 2010 Analyzer Disk; c) Software version 06-07. Recall # Z-1218-2012
a) 11804014001; b) 11804014001; c) 06526080001, 06569668001
Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated January 31, 2012.
Manufacturer: Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA, Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result, both of which are not believable since the sample was diluted due to a result that was initially too high.
13 ACCOUNTS in USA
Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures. Recall # Z-1225-2012
Lot Number: 50397157
Recalling Firm: Smith & Nephew, Inc. Endoscopy Div., Andover, MA, by letter dated February 2012.
Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. Firm initiated recall is ongoing.
Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773).
1) Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-1238-2012;
2) Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. Recall # Z-1239-2012;
3) Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease. Recall # Z-1240-2012
1) Lot Numbers: Expiration dates: 013489 11/30/2010 111530 09/30/2011 013490 01/31/2011 113463 10/31/2011 015210 02/28/2011 114259 10/31/2011 018854 03/31/2011 114260 11/30/2011 020419 05/31/2011 115484 12/31/2011 022834 06/30/2011 116658 01/31/2012 109632 07/31/2011;
2) Lot Numbers: Expiration dates: 009091 10/10/2010 109636 09/30/2011 013491 10/31/2010 113465 10/31/2011 013492 11/30/2010 113969 10/31/2011 014488 12/31/2010 114261 11/30/2011 015211 02/28/2011 115485 12/31/2011 018855 03/31/2011 116660 01/31/2012 020420 04/30/2011 118211 02/28/2012 021285 05/31/2011;
3) Lot Numbers: Expiration dates: 011167 04/30/2011 017561 09/30/2011 014486 7/31/2011
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated November 9, 2011.
The Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.
15,417 units total (2,954 units in US)
1) COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW Version: 1B1, 1B2. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Recall # Z-1241-2012;
2) COULTER LH 750 Analyzer, part number: LH750 System Help 2D1.103272, PN 6605632, PN 6605632R & PN A85570. SW Version 2D1, 2D2. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automatedmethod for enumeration of RBCs and WBCs in body fluids. Recall # Z-1242-2012;
3) COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN 178832; LH 500 Series System 120V, PN 178833; LH 500 Series System 240V, PN 178834; LH 500 Series System Remanufactured (115V), PN A91062; LH 500 Series System Remanufactured (220V), PN A90994 SW Version 2A4, 2A5. The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH 500 Analyzer also provides a semi-automated reticulocyte analysis. Recall # Z-1243-2012
1) SW Version: 1B1, 1B2. Serial Number: all;
2) SW Version 2D1, 2D2. Serial Number: all;
3) SW Version 2A4, 2A5. Serial Number: all.
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated November 30, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
The Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner.
8,922 units total (4073 units in US)
1) IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1271-2012;
2) IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5 (500 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1272-2012;
3) IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE 2000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1273-2012;
4) IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1274-2012
1) Kit lot 312, 313;
2) Kit lot 316, 318;
3) Kit lot 213, 214, 215;
4) Kit lot 136, 137
Recalling Firm: Siemens Healthcare Diagnostics, Tarrytown, NY, by letter dated January 2012.
Manufacturer: Siemens Healthcare Diagnostics Products Ltd., Caernarfon, UK. Firm initiated recall is ongoing.
Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.
1,848 units
1) Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds. Recall # Z-1131-2012;
2) Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy technologies together on a low-height frame. The lower body section provides air fluidized therapy, and the upper body section provides low airloss therapy. Recall # Z-1132-2012
The headboard (p/n 6020200003) and siderail (p/n 6020200002) are not serialized. There are no model, catalog or code number identification marks available on the accessories. It is possible to identify these accessories though by a mark stamped into the mounting post that are used to attach these accessories to the bed. May 2011 and October 2011 headboards and siderails were shipped to customers.
Hill-Rom, Inc., Batesville, IN, by letter dated February 2, 2012. Firm initiated recall is ongoing.
The Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts received from the supplier were of a two part welded construction. The weld locations of the part did not meet the design requirement, and is unacceptable as it will impact the strength of the rail.
Foot side rails=70; Headboards=103
END OF ENFORCEMENT REPORT FOR MARCH 28, 2012 #