mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
An "Urgent Field Safety Notification" letter dated January 30, 2009 to all customers with ARJO/BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars via UPS 2nd day on the February 26, 2009. The notification letter informed the accounts of the potential for clip detachments if the sling clips are not applied to the hanger bar attachment lugs. The accounts were instructed to do the following: 1) Apply the stickers provided to the passive patient lift and/or ceiling lift hanger bars as shown in the enclosed Sticker Application Instructions sheet; 2) Retrain lift operators in accordance with the enclosed instructional DVD, the revised Passive Clip Sling Operating and Product Care Instructions manual and the revised Flites Clip Operating and Product Care Instructions manual; and 3) Make lift operators aware of the Clip Sling/ Flites Clip Application Instructional poster and its location within their facility. The accounts were also instructed to complete and fax back to Arjo the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, acknowledging receipt and understanding of the Field Safety Notice. If you have any questions or require any additional information, contact the ARJO, Inc. Quality, Customer Support, or Technical Support Departments via e-mail at quality@arjousa.com, via phone at 1-800-323-1245, or via fax at 1-888-594-2756.
The firm, Integra Spine, sent an "URGENT: FIELD CORRECTIVE ACTION" letter dated January 10, 2011 with a Field Corrective Action Acknowledgement and Return Form sent via Fed Ex/ priority mail to all customers including physicians and distributors. The letter describes the product, problem and actions to be taken. The customers were instructed to review the current inventory to identify product from the affected part numbers; replace the existing IFU (22-PI-01 rev C) with the revised IFU (22-PI-01 rev D) and the existing Surgical Technique (ST-22-001 rev A) with the revised Surgical Technique (ST-22-001 rev B), and complete and return the Field Corrective Action Acknowledgement and Return Form via fax to: 877-558-6227 or email. If you have any additional questions, contact the Manager Quality Systems Integra Spine at 330-475-8646.
Customers were sent letters instructing them to remove and replace affected pages in their manuals. Letters were sent January 10, 2003.
Roche sent an "Urgent Medical Device Correction" (UMDC) notification with response form dated April 1, 2013, to all affected customers via UPS Ground on April 1, 2013. The letter identified the product, the problem, and the action to be taken by the customer. A contact number (Roche Diagnostic Technical Support) is provided for technical support 24 hours a day, seven days a week at phone number: 1-888-912-7090.
The firm initiated phone calls on 5/22/08 and explained the reason for recall and requested the product be quarantined. The customer was informed they would receive a recall letter providing instructions for return, replacement, or credit. During the phone call, some of the customers asked if they should recall to the end user level and they were told to do so, but this instruction was not verbally given to everyone. The recalling firm issued a letter dated 5/23/08 via overnight mail which explained the reason for recall and requested return of the product. The letter requests the customer to notify the end users. A Return Form was enclosed to report the amount of product being returned. The firm telephoned all nonresponders on 7/1-2/08 to assure they received the recall notification. On 7/21/08, the firm issued two different letters flagged as "Expanded Recall Notification" dated 7/21/08. One of the letters covered Product/Part numbers 811909, 812144, and 821972, which were all HACH brands. The other letter covered Product/Part number 812004, which was a private brand. Reason for recall expansion was explained and return of product was requested. If the product was further distributed, subrecall was requested to the end user level. A "Return Form" was enclosed to be completed to indicate the amount of product being returned. Some customers who tried to order product #811909 received a letter dated 7/28/08 informing them they could use their Total Chlorine DPD Test Kit, product #811902, as an alternative method for testing. For assistance, contact Hach Customer Service at 1-800-548-4381, ext. 3563.
Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The Distributor is instructed to immediately cease further shipment of the product and to physically quarantine the product, and fax the completed Response Sheet to our firm's Recall Coordinator within 5 business days of receipt of the letter. The Customer is instructed to immediately cease further use of the gowns and physically quarantine the product, and fax the completed Customer Product Response Sheet to Kimberly Clark's Recall Coordinator within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, the firm will provide instructions for the return of the impacted gowns for delivery to a quarantine location at our warehouse.
The firm plans to distribute recall letters to all customers indicated on the customer list. TELEPHONE 6/27/2005. All products will be returned to Argon and disposed.
Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.
On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.
The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.
On 1/2/07, Abbott sent Product Correction, Immediate Action Required letters dated 12/29/06 to all ARCHITECT AUSAB (list number 1L82-25) and ARCHITECT Anti-HCV customers (list number 1L79-25) who have the affected assay CD-ROM. The end users were informed that for the ARCHITECT AUSAB and ARCHITECT Anti-HCV assays, the default interpretations in the Assay Parameters window, installed from ARCHITECT I System Assay CD-ROM US Version 06E58-21, are not align with the result interpretation options in the package inserts. The accounts were advised to reconfigure the names of the interpretations in Assay Parameters window, following the steps in the enclosed attachments A and B. The accounts were requested to keep a copy of the letter on file until the revised Assay CD-ROM is received. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect AUSAB and/or Anti-HCV testing, and fax it to Abbott by 1/12/07.
The firm, TRIAD Group, sent a "Urgent Medical Device Recall" letter dated January 18, 2010 to all consignees/customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to review there inventory, cease distribution of the affected lots and to complete and return the enclosed Product Recall Response Form via fax to 1-919-570-9611 or e-mail to Apogee Medical. If they distributed the product, they were instructed to notify their customers of the recall; to include a copy of the recall notification, and to instruct them to return the recalled product to the wholesaler who would then return the product to Apogee Medical. Non-responders to the recall notice will be contacted on a weekly basis. Should you have any questions regarding this notification, please call the Regulatory Affairs/Quality Assurance Manager at (919) 435-5409.
The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated June 2013 to Distributors by fax, US customers via letters by UPS and OUS BD sites via email and teleconference. The letter described the product, problem and actions to be taken. All customers were instructed to discontinue use of the listed product; discard any remaining packages, and complete and return the attached form, whether or not you have any inventory remaining, via Fax to: Attention: Regulatory Compliance, 410-316-4258. BD will issue replacements for the discarded material. It is not necessary to contact BD by telephone to receive replacements. If you have any questions, call 410-316-4000.
Philips Healthcare is informing the consignee of this issue through a Field Safety Notice (FSN) 88200487-488. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update.
Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.
Biomet Spine & Bone Healing Technologies sent "Urgent Medical Device Recall Notice" letters with Fax-Back Response Forms dated 8/13/2013 to distributors and OR managers via Fed Ex. Follow-up e-mails with a copy of the Recall Notice were sent to distributors on 8/13/2013. Customers with questions may contact 973-299-9300 x2162 Monday to Friday from 8:00 am to 5:00 pm EST.
Consignees were sent a letter titled URGENT MEDICAL DEVICE CORRECTION dated 9/9/09, advising them of the problem and to remove the devices from service until they have been repaired. U.S. customers were notified that Stryker will complete the correction while international customers were sent a kit with instructions for completion of the correction. International consignees were told that Stryker will complete the correction if the consignee does not feel comfortable in doing so. Questions or comments regarding this issue should be addressed to Sarah Marie Puterbaugh of Stryker Medical at (800) 869-0770 ext. 6902.
Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.
On 10/16/2013 Customers were sent an Urgent field safety notice for Corrective action concerning the operating instructions of CARINAsim and CARINAiso. The letter identified the affected product, as well as the issues involved. Users were to review their current operating steps and validate their operating sequence. Users should have received a modified software version with software update in February 2014. All users should have been notified of this letter and a copy should be maintained in the users' records. Questions should be directed to Thomas Gaudet on 561-416-9250 at the Service Center.
The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge. Please call (1-800-627-2765 ) for further questions.
Agfa Corp. sent an "URGENT SAFETY NOTICE" customer letter via Agfa email to customers on 4/14/2011, along with a "URGENT SAFETY NOTICE FEEDBACK FORM," The letter identified the product , the problem, and the action to be taken by the customer. It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem. Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664. If you have any questions, please contact your local Agfa Healthcare organization.
Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.
Nanosphere sent Urgent Device Recall letters dated 2/25/08 to the direct accounts on the same date, informing them of the potential for aberrant results with the use of the affected lots of cartridges. The accounts were requested to examine their stocks for the affected lots of cartridges, segregate those found and return them to Nanosphere for replacement. Any questions can be directed to Dr. Gregg Shipp at 847-400-9115.
Recall initiated on November 25, 2008. Urgent Company Initiated Medical Device Recall - Immediate Action Required letters, dated 11/26/2008, were sent to consignees via Federal Express and included return and reply forms for consignees to respond. The letters asked that further distribution or use of any foot switch affected by this recall be ceased immediately. Attached to the letter was a document entitled "Instructions for Determining Affected Product," which provided instructions and serial numbers for determining if customers have product affected by this recall. In addition, a document entitled "Recall Instructions" was also attached. Affected product should be segregated and returned to Boston Scientific in accordance to the "Recall Instructions," and the Reply and Verification Tracking Form should be completed and returned. Customers will receive replacement product for all recalled product returned to Boston Scientific. Local Sales Reps should be contacted in regards to any questions customers may have pertaining to this recall.
Stryker Spine sent an "Urgent Medical Device Removal Notification/Customer Response" form dated July 7, 2014 to all their affected customers via Fedex. Customers were instructed to examine their inventory and hospital locations to identify the product. Fax a copy of the Customer Response Form to 855-632-9049 or email it to Spine-RegulatoryAction@Stryker.com. For questions regarding this recall call 201-760-8298.
Firm called its consignees and advised them to either return or destroy the devices which had not already been implanted.
Biomet Orthopedics sent an Urgent Medical Device Recall Notice dated April 18,2012, to all affected customers. The letter identified the reason for the recall including directions to immediately locate, discontinue use of the device, and return product to Biomet, 56 East Bell Drive, Warsaw, IN 46580. Consignees were asked to confirm receipt of the notice by calling 1-800-348-9500 extension 3983 or 3009. A FAX Back Response Form was to be filled out and sent within 3 days of receipt to 574-372-1683. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m. For questions regarding this recall call 574-371-1021.
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
TheraTest sent "Urgent Device Recall" letters dated March 28, 2012 to customers that received the affected kit, requesting them to return or destroy the remainder of the product. TheraTest issued a replacement kit to all customers that had unused product as well as any material they consumed which resulted in a failed run. Customers were also instructed to complete the enclosed confirmation form and fax the completed form back to TheraTest. Any questions were directed to TheraTest at 800-441-0771.
The firm, Ansell, sent an "URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFET SCALPEL" letter dated November 11, 2013 to its customers and posted a website notification on November 11, 2013. The letter described the product, problem and actions to be taken. The customers were instructed: Do not ship SANDEL Weighted Safety Scalpel products 2210-L, 2210-N, 2211-L, 2211-N, 2215-L, 2215-N, or 2220-N to a hospital or end user with the listed lot numbers; quarantine SANDEL Weighted Safety Scalpel products in your inventory; and complete the attached response form and return it to attention: Ansell; via fax at 818-534-2510 or email sandel-cs@ansell.com. Additionally, if you have distributed this product to other accounts, please notify them of the voluntary recall and instruct them to return any outstanding stock to you as indicated in the attachment. If you have any questions or need additional information, please contact Customer Service by calling 866-764-3327 (6:00am-5:00pm PST/9:00am-8pm EST) or email sandel-cs@ansell.com
Press release was issued 4/13/2006. Letters were sent via blast email to retailers, Pharmacists and Eye Care Practitioners on 04/14/2006.
Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.
The firm sent a notification letter dated July 2019, to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were informed that a service technician will be contacting you to schedule the retrofit service. For questions, call YXLON Service at (234) 284-7881.
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.
Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification. For questions regarding this recall call 908-253-7569.
A recall letter dated 6/9/14 was sent to all customers who purchased the Coat-A-Count Direct Androstenedione because the assay is demonstrating a higher frequency of results compared to alternate platforms. The letter informs the customers of the problems identified, risks to health, and actions to be taken. Customers are instructed to complete and return the Field Correction Effectiveness Check attached to the recall letter within 30 days.
Alere sent an Urgent Medical Device Recall letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to block all stock of the affected lot in their warehouses; discontinue use and discard all stock on hand, complete the provided Customer Verification form to document disposal, contact their primary consignees and advise them of the required discontinuation and disposal of the affected lot. For question call 877-308-8289.
Roche Diagnostics initiated a voluntary recall and the Urgent Medical Device Correction notices were sent via UPS Ground on 05/07/2015 to customers. Customers were notified of the interference and the method sheets and package inserts will be updated with the new interference claims. The firm plans to monitor any non-responding accounts and address those customers with follow-up attempts to distribute recall notices. The firm plans to conduct level B effectiveness checks via fax and phone. Until the new method sheets are available, the Urgent Medical Device Correction serves as the updated labeling. Roche is not requesting return of the affected product. Customers may contact Todd Siesky Corporate Communications Director, Phone: 317.521.3911, Fax: 317.521.4696, E-mail: todd.siesky@roche.com. For technical questions, contact the Customer Support Center at 1-800-428-2336
On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.