mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
Arrow sent an Urgent Medical Device Customer Notification letter dated March 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Arrow is in the process of updating the labeling; in the meantime they wanted to instruct all customers to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU. In addition, they are placing an insert card in kits for the specified product codes alerting them that Renografin-76 is no longer available and to select a contract medium with a viscosity of 8/4 centipose or lower for use with the pressure and flow setting specified in the current IFU. Arrow remains committed to providing high quality, safe and effective products. If you require additional information or clarification regarding this matter, please contact your Sales Representative or Arrow's Customer Service Department at (866) 396-2111.
The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing.
Stryker Orthopaedics sent an "URGENT: PRODUCT RECALL" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice.
Stocks were pulled from U.S. consignees on or before 1/11/08. Consignee and implanting surgeon letters dated 6/20/08 were sent advising of the issue and recommending patient monitoring. For assistance, contact Portland Orthopaedics at 1-810-329-3348.
Consignees were contacted by telephone on 5/3/10 and if not reached, were sent a Rochester Medical "Urgent Medical Device Recall" letter on 5/6/10 dated April 26, 2010. The letter was addressed to Rochester Medical Corporation Customers. The letter described the problem and product involved; recommended consignees to record the quantity and lot numbers (s) on the enclosed postcard and return it to them; and to immediately destroy the product with the lots affected. In the case of distributors, the telephone call was followed by a letter sent/dated April 27, 2010 to each distributor. It advised distributors to isolate any remaining inventory with the specified lot numbers and to complete the disposition report. Letters included a customer letter for dissemination to their retail level customers. Retail customers were asked to segregate and destroy the affected products and record the action. The company will replace the destroyed product. The distributors started their contact to consignees on 4/28/10. Please contact Rochester Medical at 1-800-243-3315, or the firm's Customer Service Department at 1-507-533-9309 for additional information or for product return & replacement instructions.
Urgent Product Recall letters dated 9/5/08 were sent on the same date via first class mail to the direct accounts, to the attention of the Director of Biomedical Engineering and Facility Risk Manager. If the account had device(s) that had been serviced by Baxter with a part affected by this action, a serial number list of the affected device(s) was provided with the notification. Customers were instructed to remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for the customer and they wish to perform self-service, the customers will also be provided with a Service Bulletin to provide instruction on replacement of the rear case assembly.
The firm, CooperVision sent an "Urgent: Company Initiated Voluntary Medical Device Recall - Contact Lenses" notification letter to all affected consignees. The notice identified the product, the problem, and the actions to be taken. The letter includes an attached "Recall Response Form" that consignees are required to complete and fax to (585) 889-5688. Consignees were instructed to immediately examine their inventory, stop any further distribution, quarantine and return product subject to recall. In addition, consignees were told if they have further distributed the affected product to notify customers at once of this product recall. The letter states that accounts will either be credited or exchanged for an unaffected product. If you have any further questions, call 1-800-341-2020.
Becton Dickinson Diagnostic Systems notified distributors by fax on June 13, 2013, and advised consignees to discontinue use and discard affected product for credit. Distributors were requested to return their distribution list to BD for direct notification by the recaller. End users were contacted by letter on June 13, 2013 and the notification addressed to Microbiology Lab Director/Risk Managers advised that a small number of tests associated with the referenced lots of product may exhibit invalid internal negative control results. If encountered, the issue would result in an invalid test, as described in the package insert. End users were requested to discontinue use of these lot numbers, discard any remaining packages for replacement and return the enclosed response form. Customers with questions were instructed to contact BD Technical Services Department at 1-800-638-8663. For assistance regarding replacements customers were instructed to contact BD Customer Service at 1-800-675-0908. For questions regarding this recall call 410-316-4054.
Roche Insulin Delivery Systems sent urgent Product Recall letters, dated 2/21/2011. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The firm requests that customers discontinue use of the ACCU-CHEK FlexLink Plus infusion set and return the unused stock. Customers are to contact their health care provider to determine if changes to their pump therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The attached Customer Reply Card should be completed and return via mail or fax per the instructions on the card. The letter also lists some additional information pertaining to signs and symptoms. Questions regarding this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, 7 days a week.
On July 1, 2014, Zimmer, Inc. issued recall notification to their consignees via e-mail and/or letter. Notification included affected product issue and instructions for returning the affected product. All distributors were notified via electronic mail. Hospital risk managers, as well as distributors with affected inventory were also notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory. Distributors are responsible for returning on-hand affected products to Zimmer and ensuring all of their products are accounted for using the form provided in the letter. Hospital risk managers were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.
Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS.
Customers were sent two GE Healthcare "Urgent Medical Device Correction" letters one dated April 9, 2013, and the other May 22, 2013, each addressing one of the 2 groups of MR Products involved in the recall. The letters were addressed to Hospital Administrators / Risk managers, Radiology Department Mangers and Radiologists. The letters described the Safety Issue and provided Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected systems by providing a software update at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. Contact your local service representative if you have any questions concerning this notification. For further questions please call (262) 513-4122.
Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 30, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers who use the Auto-Stop or Auto-Transmit to ensure the settings are enabled in Control Setup after scanning the assay sheets. Additionally, a Response Form was included for customers to complete and return. Contact Beckman Coulter Customer Service at (800) 526-7694 for questions regarding this notice.
Smiths Medical notified consignees by letter dated November 28, 2011 titled: Urgent Field Safety Notice. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to inspect inventory and segregate unused affected product. Distributors were instructed to immediately stop distributing and quarantine all inventory. The letters included a Confirmation Form to be complete and return, by fax to 781-610-9859 or by email to hotlineconnectorrecall@smiths-medical.com. For questions consignees were instructed to contact Smiths Medical at 1781-763-9330.
Carefusion sent an "URGENT: Medical Device Recall Notification" letter dated January 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to return all recalled product directly to the distributor from whom it was purchased immediately, complete and return the enclosed pre-addressed and postage paid mandatory Customer Recall Response Card and to contact your distributor directly, or call the Carefusion Support Center, if you have any questions. For questions Recall Related Questions contact CareFusion Support Center at 888-562-6018; 7am to 4pm (Pacific). For technical questions contact Technical Support at 888-812-3229, 7am to 5pm (Pacific).
On October 8, 2014, Stryker Instruments issued "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to their consignees. Notification included affected product description, reason for recall, risk to health, and actions to be taken by the customer/user. The customer/user were instructed to immediately review this recall notification, check all stock areas; discontinue use of any product which shows sign of cracking or damage at the weld; and complete and return the enclosed Business Reply Form (BRF) via fax to Stryker Instruments Regulatory Department, 866-521-2762 or scan and email a copy to kara.spath@stryker.com. Upon receipt of completed BRF, a replacement product will be shipped and the customer/users, upon receipt of replacement product, are to remove and return all recalled product from use and replace them with new product. For questions regarding this recall, please contact Stryker Instruments: at 269-389-4518 or email: kara.spath@stryker.com.
Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
All domestic end-user consignees were initially sent "Important Product Correction Notification" recall communications (dated 5/10/11) by Federal Express overnight mail on 5/10/11. The letters informed users of the issue, and advised them to discontinue using their VITROS VALP reagent until adjusted calibrator values are provided for GEN 14 of VITROS VALP Reagent. The adjusted calibrator values for VITROS VALP Reagent were sent to customers via Assay Data Disk (ADD) Data Release Version (DRV) 5632. Customers were to refer to the Technical Support Communication for details. Users were to confirm receipt of the notice by completing and returning the Fax Reply Form - Confirmation; confirm that all customers or distributors were informed of the issue and instructed to discontinue use of affected product; and lastly confirm that all customers or distributors were sent adjusted calibrator values.
Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500.
Argon Medical Devices Inc. issued an "Urgent Field Safety Notice" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396). For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319.
The firm notified their consignees of the recall by letter and email on 12/02/2013 instructing customers not to use the containers until further notice from Symmetry Surgical.
Linvatec has issued recall notification to all it''s direct accounts. The mailings were sent by UPS 08/31/2005. Each consignee was requested to return the affected product to Linvatec for a free replacement footswitch.
An Urgent Medical Device Recall notice, dated May 2015, was sent to affected customers to inform them about the issue and associated risks. Customers were asked to discontinue use, distribute this information to all appropriate personnel, and to complete and fax back to Siemens the Effectiveness Check form.
Epocal Inc. sent a Voluntary Product Recall letter dated June 27, 2011 to the affected consignee. The letter identified the affected products, problem and actions to be taken. The letter ask that all products affected by this recall be sent back to Epocal and a replacement may be obtained. For questions call 1-613-738-6912.
On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line. International Distributors. International distributors provided with the Recall Authorization' package and the customer letter. Accounts are requested to complete the Recall Reply Form acknowledging receipt of the notification. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.
Covidien sent an Urgent Product Recall letter dated May 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused devices to Covidien, their account would be credited. Customers were also instructed to:: 1) Stop using product listed in this letter immediately 2) Segregate this product from other inventory 3) Fill out the reply (verification) form at the end of this letter ¿ If you do not have any product identified in this letter, please fax or email the completed form to Covidien at (877) 523-9109 or covidien8770@stericycle.com. ¿ If you do have product, your sales representative will assist you in completing the verification form and arranging for return of the product. ¿ Please fax the completed form to Covidien (877) 523-9109 or email to covidien8770@stericycle.com. 4) Your sales representative will be available to answer any questions regarding this recall and assist you in completing the verification form, returning product and addressing any account credits. This action is being conducted with the knowledge of the United States FDA and other regulatory authorities. ¿ Customers with questions were instructed to call (202) 310-5120. For questions regarding this recall call 202-310-5120. _
On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.
Animas initiated the notification to Distributors by letter, dated July 2012, and Patients and Health Care Professionals were notified by letter in September 2012. The delay in notifying patients and health care professionals was driven by the need to have sufficient inventory of replacement product on hand in order to meet anticipated demand before sending the letters.
SCC Soft Computer's proprietary Task Management System sent a correction communication letter to all consignees with affected software. The letter identified the affected product, problem and corrective actions to be taken. The letter also recommended alternative working solution if the corrective actions cannot be used. Consignees with affected software are scheduling receipt of the software correction. For questions call 727-789-0100.
Enhancement Medical, LLC called all Independent Sales Representatives and then provided each representative a list of consignees with impacted product and instructed the Representatives to disclose low gel weight issue and potential for common treatment responses. Representatives were instructed to exchange the affected product. EXPANDED Enhancement Medical sent an Urgent Medical Device Recall letter beginning July 8, 2014 to all consignees whom received product. The letter identified all lots as being recalled, the reason for the recall, recommended that Expression not be injected subcutaneously, and asked for product to no longer be used and be returned to the recalling firm. An acknowledgement Form was asked to be mailed, e-mailed or faxed back to the firm. Customers with questions were instructed to call 414-918-4280.
On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.
Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.
On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.
Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.
Firm initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and an Urgent: Device Field Correction letter to consignees was sent via UPS. The letter recommended that customers check their infusion pumps and spare parts in their inventory to determine if the specified AC Power Cords are in use at their facility; and, to inspect the affected cords for bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear. Also, it was recommended that customers immediately discontinue use of the affected cords exhibiting the described characteristics and contact their local Hospira representative for assistance. The letter stated that customers may continue to use and monitor cords that are not exhibiting the described characteristics until replacement cords are sent to their facility. Hospira will contact customers to schedule replacement. Customers are to complete and return the attached Reply Form. Question should be directed to Hospira Customer Service at 1-800-241-4002.
The firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259.
On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.