mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
On August 10, 2005 the firm began notifying consignees via phone and began follow up with notification letters on August 12, 2005. Consignees are being asked to return product. The firm subsequently extended its recall after lots manufactured in June 2005 were tested by FDA and failed the sporicidal testing. The firm identified recipients of the affected product and began to contact them by phone on October 3, 2005. The firm began follow-up notification via mail on October 6, 2005. All customers are requested to respond directly to Pascal regarding disposition of any remaining product.
Notification of customers initially began November 15, 2007 based on a cursory visual inspection of the defective needle tips. The initial letter advised that there is a possibility that the Flexiguide Needle tip is defective in that there is the potential for the needle's stylet or an HDR source wire/cable to puncture through the defective needle tip during implant or treatment and penetrate the surrounding tissue thereby injuring the patient and/or breaking the sterile boundary. Further distribution and/or use of these products should not take place. The recall notification was updated on November 27,2007 once results from actual testing were available. The letter advises that there is a potential for the needle's tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids. Further distribution and/or use of these products should not take place. Customers are to return the products for credit. A response form is provided. Contact Alpha-Omega Services, Inc. at 1-800-346-7894 for assistance.
The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.
Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.
Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled "URGENT MEDICAL DEVICE RECALL," informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account. The consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address: KerrHawe SA Via Strecce 4 CH-6934 Bioggio Switzerland PLEASE LABEL RETURNED PRODUCT "RECALLED PRODUCT RETURN". In addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14
Sarin Group US distributed a Field Safety Notice dated December 5, 2013 to all affected customers and distributors. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite. Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call 303-467-6527 or 303-467-6503.
Beevers Manufacturing and Supply, Inc. (BMS) of McMinnville, Oregon, began notifying consignees about this recall on 1/18/2007. Customers were advised to inspect blue box that say size 2 (CA 102) and check if size 1 (CA 101) was packed inside. Salter Labs provided BMS' recall report to FDA in October 2014.
Biomet 3i sent an Urgent Medical Device Field Correction Notice dated July 2013 to all affected customer via email, facsimile, or postal mail. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete the attached response form and fax to 561-514-6316. For questions contact Biomet 3i customer service at 1-800-342-5454.
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks. A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
The recalling firm has decided to inspect all of the installed units for this condition and where necessary replace the missing clip. The recalling firm has issued an Update Instructions AX011/09/S dated 03.09, which provides instructions on how to perform a visual inspection of the Mavig Portegra 2 arm for the presence of the safety clip and the installation instructions on how to properly install the clip if it is missing.
An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.
The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
Customer Product Correction Letters (CL2014-143, dated 5/12/14) were sent on 5/12/2014 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected calibrator lot(s), and inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Distributor letter (DL2014-143) was also sent on 5/12/2014 via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and the required actions. Foreign affiliates were pre-notified via e-mail on 5/08/2014 that the communication of this issue and required actions is imminent and were sent the finalized recall communication on 5/12/2014.
The recalling firm has respresentatives/engineers hand carrying Customer Advisory Letters to their customers. The engineers are temporarily reconfiguring the ssytem to allow routing to only two network nodes in order to prevent this issue from occuring.
A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s representatives.
Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices. Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall.
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email. For questions regarding this recall call 901-396-2121.
An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.
A Customer notification letter dated 6/27/16 informs their customers that Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery. The letter informs their customers that the DxC No Foam reagent is intended to prevent formation of foam and/or bubbles in the DxC waste system of the hydropneumatic subsystems. Over time, this incompatibility may lead to: Breaks in No Foam Cap Assembly (PN A84827) and Cracks in No Foam Waste Collector (PN A60007/A64665). The letter informs the customers of the impact and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the recall notice are instructed to contact our Customer Support Center Via http://www.beckmancoulter.com/customersupport/support ¿ Via phone, call 1-800-854-3633 in the United States and Canada. Customers outside the United States and Canada, are instructed to contact their local Beckman Coulter Representative.
Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.
Customers notified by letter (Product Field Action letter) on September 23, 2008 and instructed to remove and return any affected product to Bard Access Systems, Inc (BAS). Customers were instructed in the recall letter to respond by completing and faxing the enclosed Reply Form and Inventory Reconciliation Form. For assistance, contact BAS customer service at 800-290-1689.
AM2PAT contacted their distributors by phone on or about January 17, 2008 and instructed them to stop distribution of their pre-filled syringes and to contact their customers to recall all AM2PAT manufactured lots and all sizes of prefilled, Heparin Lock Flush syringes and Normal Saline IV Flush syringes (B Braun and Sierra Brands) to the consumer level. A press release was issued on January 17, 2008. The firm had eariler on 12/20/2007 recalled a single lot of Heparin syringes, the January extension was to all lots/all sizes of its Heparin and Saline syringes.
Stryker Instruments sent an "Urgent Medical Device Recall notification" dated January 13, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : Immediately check all stock areas or operating room storage and quarantine any affected product found. Mark product as RECALLED PRODUCT. Please indicate on the BRF the quantity of affected Pressurizers you are returning and fill in the form completely. Sign the BRF (even if you do not have any affected product). Note: Your signature on the BRF indicates that you received and understand this notification and are returning all affected product from your facility. Fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. Upon receipt of the BRF, Stryker will contact you to coordinate the return of all affected product that you have on hand. Send back all affected product using the pre-paid shipper provided to you by Stryker. Upon receipt of the product, a replacement will be issued to your account
Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.
A Device Correction Letter was issue by the firm on 02/25/2008. The letter asks the affected customers not to use the value of ICA/CCA on the Measurement Report for diagnosis, but instead to follow the Immediate countermeasure detailed in the 'Note in Use' document which accompanies the Device Correction letter. The customers are asked to follow the Immediate Countermeasure until they receive a Temporary Countermeasure to correct the ICA/CCA ratio calculation. The Temporary Countermeasure will include: 1) a Disk to import a new carotid measure package; 2) an Installation booklet detailing how to import the new carotid measurement package and optional customization tools; and 3) an Operator manual addendum Upon release of the countermeasure, the firm's Applications or Servcie personnel shall perform the corrective action as identified in the Service Pack (A) Installation Instructions. Finally, upon release of the next software revision, service personnel will replace the software at each customer location.
Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component.
Consignees were notified by letter on 12/13/2007. The letter contains a diagram illustrating the error on the incorrect card and a diagram illustrating the corrected card. Consignees were instructed to discard the incorrect card if they still have it and to complete a response form and return it via fax to Given Imaging.
Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction. The Notification letter instructed their customers to: 1. Locate the gurneys with the serial numbers listed in this advisory. 2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location. 3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely. 4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional. 5. Contract Sechrist for the replacement parts package. 6. Complete the retrofit of the Gurney. 7. Verify correct function of the brake assembly following retrofit. 8. Complete and send the Correction Verification Form contained in the package to Sechrist.
An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.
The recalling firm telephoned the distributors to inform them of the problem and the need to return the product.
A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.
Cardinal Health sent an Urgent Product Recall letter dated December 18, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immedaitely stop using affected product and discard any product that may be on hand, return the enclosed acknowledgement form, notify any customers to whom you may have distributed product affected by this recall, and contact the appropriate Customer Service group to arrange for credit of any affected product discarded. For questions contact Cardinal Health Professional Services at 800-292-9332.
Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by: Fax: 866-229-7778 Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
On January 25, 2008, letters were sent to all existing Esprit distributors in > 200 volt countries. This letter notified customers of the pending field action, the reason for the action and included a set of instructions that end users need to follow in order to be able to continue using their Esprit pending the installation of replacement parts. The letter also stated that as soon as replacement parts are available, customers will be provided with a serial number list of their affected units. Respironics will provide replacement parts at no cost and instructions to upgrade the Esprit Ventilators and FRUs in each distributors respective region. Contact Respironics California, Inc. at 1-760-918-7328 for assistance.
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
Winco sent a Chair Field Correction Notification dated September 24, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to forward the "Field Correction Form - REPAIR" form back to Winco and the firm would send a Winco Representative to the consignees' facility to correct the chairs in the field. Customers with questions were instructed to contact Winco at 800-237-3377 or email customerservice@wincomfg.com. For questions regarding this recall call 352-854-2929, ext 110.
Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.
Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
The firm, LifeWatch, sent an " Urgent Device Recall" letter dated September 27, 2011 to the affected customers. The letter describes the product, problem and action to be taken. The customers were instructed to immediately refrain from providing these devices to their customers; stop using the affected sensors, return their entire kit in the pre-paid mailer, and use the new device kit included with the recall letter. In addition, the letter informed the users that the replacement device has upgraded software and firmware that allows for detection of shorts in the cable, and if detected, cuts off current flow to the patient to prevent minor shocks and burns. If you have any questions, please call (847) 813-4258.
Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.
Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¿¿ DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.