mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
Instrumentation Laboratory sent an Important Product Correction letter on July 19, 2013, to all affected customers. On July 23, 2013, the same communication was circulated by the IL International Group in Milan, Italy to the affected international distributors and dealers. The interim field notification was followed by the release of corrective Software V5.1.0 and Parameters P-16.3.00 (Phase II) on September 30,2013. Consignees were advised of a potential carryover issue and a workaround was provided. Consignees were asked to fax the Mandatory Response Tracking Form to 781-861-4207 or email to ra-usa.ilww.com For technical questions customers were instructed to contact the IL Technical Support Center at 1-800-678-0710, option 2. For product availability questions, customers were instructed to contact their IL Customer Service Representative at 1-800-955-9525, Option #2. For questions regarding this recall call 781-861-4467.
Stanley Security Solutions, Inc. sent an Important Recall Notice dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease using any of the affected product. The customers were informed, however, that they may continue to use the units as long as they were powered with a 9-volt alkaline battery in accordance with current instructions because the issue only occurs when using the 12V DC adaptor. The letter also informs the consignee to expect a follow-up notice no later than 6/1/12 that will provide additional instructions. The recalling firm issued additional letters dated 6/5/12 to distributors and end users with updated instructions. The letter informed them further testing revealed the possibility that a subset of affected monitors may also fail to alarm when powered by a 9V battery if weight is rapidly applied and removed from the pressure pad. Therefore, the recalling firm decided to recall and repair this subset of affected monitors and provided the serial number ranges that must be returned for repair. The letter also provided a list of serial number ranges that could be corrected in the field by permanently blocking access to the 12V DC jack on the monitor. Instructions were enclosed to show the customer how to disable to the jack. In addition the distributor letters request the customer to provide the recall information to their downstream customers. A response form was included to report the amount of affected product in the customers' inventory. For questions customers were instructed to call 888-224-2460. For questions regarding this recall call 407-271-2097.
The firm, Solta Medical, issued three "DEVICE CORRECTION" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further. If you have any questions, please call Solta Product Support at (510) 259-7291.
On July 1, 2014 Zimmer, Inc. issued recall notification to their consignees via letter. This notice was issued to affected distributors and hospitals with instructions for returning the affected product. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product and providing related contact information (name, address, and phone number). Distributors are to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative.
RC2/The First Years initiated recall by email with recall letter on 1/27 /06. Buyers will advise retail stores to remove product from retail shelves and return to First Years for replacement. The firm is posting the recall to their website: www.thefirstyears.com. A Press Release was issued to AP on 1/27/05.
The firm, Surgical Appliance Industries sent an URGENT: MEDICAL DEVICE RECALL letters dated November 7, 2011 to all affected customers. The letter described the products, problem and actions to be taken. Customers were instructed to immediately examine their inventory and quarantine all product(s) subject to recall for return and exchange. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were asked to complete and return the enclosed Recall Response Form. For any questions contact Quality Systems Manager, at 513-271-4594 ext. 282.
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form.
Notification letters and Product Accountability Forms were sent to consignees via Fed-ex on March 9, 2005 with return receipt. An advisory notice was sent to Canada and International distributors on March 9, 2005. For information on this recall, contact Rita Intorrella at 201-831-5825 or Greg Schack at 201-831-5399.
GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local service representative.
The recall is being conducted to the user level. All consignees will be notified by US postal Service letter dated April 10, 2006, first class mail, followed by a phone call. They will be instructed to check their inventory for the lot number of the recalled gloves. Customers who have the product on hand should call the firm at 904-332-4141 to make arrangement for pick up and replacement of the product.
Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.
All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites.
The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form. If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.
BioMerieux sent an Urgent Product Correction Notice (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786," letter dated March 30, 2011, via Fed EX on April 4, 2011. to all affected customers. The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Tazobactam (TZP2). The new cards will begin shipping by July 16, 2011, but in the meantime, the cards currently in possession of the customers can be used with specific required actions that need to be followed. Until the TZP redevelopment is completed and a resolution can be implemented, BioMerieux requires their customers to immediately take the following actions: The customers will be required to suppress the TZP2 resistant and susceptible results for Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, and Salmonella enterica and use an alternate method of testing. In addition, the customer is to suppress the TZP2 resistant result only for Klebsiella pneumonia and use an alternate method of testing. The letter provides instructions for configuring the VITEK 2 software to suppress the results from reporting. The instructions contained in the recall notification are to be applied to all current and future product lots that contain TZP2 until further notice. The customer is to complete the enclosed acknowledgement form and return it via FAX to acknowledge receipt of the notification and is requested to file the correction notice with their VITEK 2 Systems permanent records according to their internal policy or procedure. For questions or additional information customers were instructed to call 1-800-682-2666, option 3. In addit
Medtronic Navigation notified Field representatives on 11/27/07 to perform site visits to implement FCA 2007-005 - O-Arm Intraoperative Imaging System Accuracy, and deliver the Customer Letter notification. Confirmation of the visit was documented.
Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative. 5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.
The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.
Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682.
The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.
Siemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157.
Biomed Inc. sent an Urgent Medical Device Recall Notice dated January 25, 2012 to distributors, hospitals, and OR managers via US mail. The notice identified the product, description of problem, possible adverse health consequences, and actions to be taken, including directions to immediately locate devices and stop device use ,with directions for return. A copy of the correct package insert was included with directions to report any procedures performed outside of indications for use. Receipt confirmation was requested by calling 800-348-9500, extension 3983 or 3009. The notice included a list of units invoiced to the account with a FaxBack Response form to be filled out and sent to the Attention of Angie Dickson, Biomet, 56 East Bell Drive Warsaw, In 46580. Questions concerning the recall should be directed to 574-371-3983 or 574-371-3009, M-F 8-5PM(EST)
Stryker Spine branches that received the recalled product were notified of the recall by an Urgent Product Recall letter, dated January 15, 2010, sent via Federal Express. The letter identified the affected product and the issue involved. It also discussed the potential hazards, risk mitigation, and the return process. Customers are to examine their inventory and hospital locations to identify the product. Customers are also to reconcile the product by utilizing the Customer Response Form and distribution sheet. In addition, they are to retrieve and return the affected product. Questions should be directed to Tiffani Rogers at 201-760-8206.
Consignees were sent a letter "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" dated February 22,2008. The letter described the Issue, Product Affected, Cause, Recommended Customer Action and Resolution. If you have not received this letter or have questions, contact the firm as outlined below: North America: 1 866 368 4807 Belgium: 0800 38783 France: 0805 631 565 Germany: 0800 000 7541 Italy: 800 986 399 Netherlands: 0800 0201364 Spain: 800 300049 Switzerland: 0800 001927 United Kingdom: 0808 238 6035 China/CNC (Northern): 10 800 712 1701 China (Southern): 10 800 120 1701 Hong Kong: 800 967912 Japan: 0044 22 132374 Singapore: 800 1204 683 South Korea: 0079 81 4800 7204 All other locations: +1 608 824 2900 or +32 2 400 44 44
The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying customers.
An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to: (1) Share this information with their laboratory staff and retain the letter for their Quality System documentation, (2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coulter, Inc. can be assured that the customer received the notification, and (3) Contact Customer Technical Support at 1-800-854-3633 or your local Beckman Coulter, Inc. representative for questions or additional information regarding the notification.
An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.
Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts.
GE Healthcare will notify customers with affected systems via letter and enclose a new CD- Rom, along with notification that a GE Representative will schedule an appointment to install the User's Manual along with a GE Service Engineer will go on site to install it on the control station of the Senograph Essential system. 16- H LA 6. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter. GE Healthcare will secure and summarize documentation that the manual has been installed and is available on each affected system and provide summarize of the documentation to the district recall coordinator. For further questions please call ( 262 ) 513-4122.
Smiths Medical telephoned the customer on December 23, 2009, to return the CADD-Legacy¿ 1 Ambulatory Infusion Pump, serial number 370969, since there was no record of the completed accuracy testing for the infusion pump.
Accuray sent an "Urgent Field Safety Notice" dated November 21, 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customers. For questions they can contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solutions Center at www.accuray.com>Services & Support or call: North America: +1.877.668.8667, Europe: +800.4141.9595, Hong Kong: +852.2247.8688, Japan: +81.3.6269.9556. Requested consignees to complete and return the Acknowledgement Form to Accuray Regulatory Affairs.
The recalling firm notified distributors by phone on 06/17/05 to hold product and followed with a letter and fax to distributors and direct account retailers on 06/21/05. Notification instructed distributors and retailers to discontinue selling the product and return product. Distributors were requested to notify all of their consignees with the 'retailer alert' notification provided.
The firm, Covidien, sent an "URGENT MEDICAL DEVICE VOLUNTARY FIELD CORRECTION" letter dated January 24, 2014 to its Consignees/customers via certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to read and understand the enclosed information; communicate this information to those who need to be aware of this labeling update; for the Puritan Bennett 840 ventilator only: If you have addendum P/N 066009A 09/02, remove and discard the addendum and replace it with the new information in Attachment I; for the Puritan Bennett 740 and 760 ventilators only: Add the new information in Attachment I; Ensure all O2 sensors in use or in inventory conform to the instructions in this notification. to your current operators manual and service manual, and read and understand the warnings, cautions and notes related to safety, ventilator use and operation that are contained in the Preface of the Operators Manuals. are asked to remove incorrect labeling and replace with the revised labeling. Covidien enclosed a labeling update (Attachment I) which provides detailed information related to the life of oxygen sensors used with the Puritan Bennett 840, 740 and 760 ventilators. Covidien has validated another oxygen sensor, P/N 10097559, for use in the Puritan Bennett 840, 740 and 760 ventilators. Information about that sensor is also included in the update in Attachment I. Should you have any questions regarding this letter or to report any issues with the Puritan Bennett" 840, 740 or 760 ventilators contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1, to ensure proper device reporting procedures are followed.
On 5/1/07 the dental office contacted the manufacturer via telephone regarding the incident. On 5/2/07 the firm's service representative visited the dental office and replaced the lights.
Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers.