mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
Urgent Recall Notice dated 08/04/05 was Federal Express''d to customers for delivery on 08/05/05. This notice informs customers of the issue and identifies affected product. Customers are asked to immediately discontinue use of and segregate these recalled lots. Steps for Voluntary Recall and Tracking/Verification Form were sent to the Risk Manager only. The Tracking/Verification Form is to be completed by the Risk Manager even if there are no affected lots to return. To return affected product, the customer must call Boston Scientific Corporation (BSC) to obtain a Returned Goods Authorization (RGA) number. Returned Goods are to be packaged and sent to BSC with the Tracking/Verification Form and using the enclosed red/white field action return shipping label to: Boston Scientific Marina Bay, 500 Commander Shea Blvd., Quincy, MA 02171
Product Advisory Notices were sent via e-mail on 3/12/09 to Roche Local Safety Officers and Roche county General Manager. Local Safety Officers and General Managers were to communicate to the end users with the Important Product Notice. In addition, Reagent Bulletin 09-052, dated 3/27/09, was issued to Roche U.S. Affiliate of U.S. customers.
The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.
Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.
The firm, STERIS Corp. prepared an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated December 8, 2011. The firm intends to send the letter to its customers upon STERIS' receipt of 510(k) clearance from FDA. The letter includes a description of the Product-SYSTEM ¿¿ Liquid Chemical Sterilant Processing System, problem and actions taken. The customers were instructed to in case of an incomplete or cancelled cycle, reprocess devices in the cycle following the directions in the Operator manual. The letter also states that STERIS Corporation will install updated software on the affected system, and will be providing the customers with a new Operator Manual reflecting the revised wording resulting from the installation of the new software. For further information or if they have any questions regarding the firms visit to their facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, contact Director Low Temperature Sterilization, at 440-392-7455.
Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007. The letter instructed users to check their inventory, remove any affected product and place them in quarantine. It also included instructions for returning the product. Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form.
Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories.
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notice dated October 11, 2006 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were informed that a GEHC OEC would be contacting their facility to verify the current software version installed at their site. If the issue affects their facility a software upgradewill be provided at no cost. Customers were advised to excercise caution when using the affected product until the 5.2.1software upgrade is completed. For question contact GE Healthcare Customer Service at 1-800-874-7378, option 1 or 1-801-536-4688, option 1. For questions regarding this recall call 801-536-4516.
Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product. Further information is available at +011.49.719.447.2539.
Baxter sent the 6/13/05 Urgent Device Correction letter to all Baxter 6060 and 6060E Infusion Pump customers to inform them of a software anomaly which allows the pump to overinfuse in the Intermittent mode of the 6060 pump if the following specific sequence of events occur: * the infusion is running in intermittent mode; * the pump is delivering at the Keep Open (KO) rate; * the pump is then powered off and on; * the clinician initiates new programming of the pump by selecting NO at the 'Resume KO Dose 1?' prompt and selecting YES at the 'Yes to Program' prompt; * the clinician powers the pump off and on again; * and the clinician selects YES at the 'Resume KO Dose 1?' prompt. Until the software upgrade is available, Baxter recommended that the accounts notify healthcare providers of the potential for an overinfusion condition in Intermittent mode if the above sequence is performed during an infusion, and to utilize the Lockout mode after programming the pump. Any questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867. The letter also informed the accounts of two patient deaths due to medication delivery errors resulting from improper programming of the infusion parameters into the 6060 and 6060E pumps, and reports where the infusion parameters were modified by untrained individuals, which may result in overinfusion or underinfusion conditions. The letter stressed that programming of the pump must be performed only by trained clinicians, or healthcare providers trained and deemed competent by trained clinicians or under the direct supervision of trained clinicians; the Lockout mode feature of the pump should be used to prevent unauthorized changes to the pump programming; and the pump security codes, which disable the Lockout mode, must not be released to anyone other than trained healthcare professionals. A copy of the warning from the Operator''s Manual was included with the letter. Any questions were referred to the Center fo
The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.
International Technidyne Corp. (ITC) sent "Urgent Medical Device Recall" letters dated May 10, May 25 and June 09, 2011 to all affected customers. The letter included a description of the problem, asked customers fill out the attached form, and return affected product for replacement. For questions, please contact ITC Technical Support at (800) 631-5945.
Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
A Product corrective action letter to be mailed the week of August 8, 2005, to all customers directing that each patient is identified with a truly unique patient identifier.
Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.
Letters were sent to all customers by first class US mail, certified receipt requested on 10/10/2006. Customers were also notified by fax and e-mail and a phone call on the same day.
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Integra issued a Field Safety Notice with an attached Acknowledgement and return Form to all Integra Sales Representatives and Customers via Fed Ex and E-mail on May 19, 2011. The Field Safety Notice informs the customers of the firm's receipt of information concerning several reported incidents that lead to the misalignment of the calcaneal of tibial when used with the Panta Arthrodesis Nail Support Device. The notice goes stated that Integra determined that the misalignment of these screws may be attributed to improper surgical technique and to that end, the Field Safety Notice is being issued in order to reinforce the importance of following the recommended guidelines our lined in the product's Surgical Technique Manual (a copy of the referenced guidelines are provided with the Field Safety Notice (FSN). The FSN goes on to direct the reader/customer to applicable section sections of the manual to which particular attention should be directed in order to minimize the potential for misalignment of the screws. The customers are asked to distribute the information provided to the surgical teams at their various institutions. Moreover, they are also asked to sign and return the enclosed Field Safety Notice Acknowledgement and Return Form so as to document their receipt of the notification and the material provided. Should the customer(s) have questions, they are directed to contact Sean Luland, Director of Marketing-Lower Extremity Reconstruction at Integra LifeScience at: 513-533-7929, for additional information. For questions regarding this recall call 609-275-0500.
Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated October 23, 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 check inventory and remove affected stock, call Synthes to obtain a Return Authorization for the device, and to return the completed verification section of the response form by fax to (610) 430-7083 or Scan/email: Fieldaction@synthes.com. Customers with questions were instructed to call 610-719-5450.
Customers were notified by letter on March 23, 2004 to contact their LIS vendor and to reconfigure the ASTM Field 10.1.4 to allow a maximum character length of 20 characters.
Baxter sent the 12/6/06 Safety Alert letter to all Colleague Infusion Pump customers, to the attention of the Director of Radiation Oncology with copies to the Medical Physicist and Vice President of Nursing, via first class mail to advise them that the Colleague pump is not recommended for use in Linear Accelerator radiation therapy suites. The letters informed the users that there is a potential for a corruption of the memory chip to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user. The letter listed the error codes that may occur if the pump has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was requested to submit the pump to their service facility. Failure code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedical services organization. Any questions were directed to Baxter Global Technical Services at 1-800-843-7867, prompt 2.
A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC representative.
Roche sent an Urgent Medical Device Correction (UMDC) letter dated May 20, 2014 via UPS Grount (receipt required) to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Follow the instructions in the Precautions Regarding Handling the Aspiration Tube Filter section in this UMDC; 2. Discontinue performing ProCell/Clean Cell aspiration tube filter check as this maintenance item will be performed by your Roche FSR as a part of service maintenance; 3. If you have distributed the products listed within this UMDC to other sites or facilities, please provide them with a copy of the UMDC; and 4. Complete the faxback form enclosed with this UMDC and fax it to 1-888-410-6620. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Thoratec Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 30, 2010, to all customers. The letter described the affected product, description and symptoms of problem, and immediate action to be taken by the customers. The customers were instructed to: 1) contact all ongoing patients using the affected Systems Controllers (serial numbers starting with "EPC") to determine if they are experiencing any unexplained intermittent alarms or have any bent pins in the connectors between the System Controller and the power sources, if so, have them return to the hospital so that their power leads can be examined. If further assistance is needed with the evaluation, please contact Thoratec Technical Service (800-456-1477). 2) review the attached addendum to the HeartMate II labeling with all VAD clinicians and ongoing HeartMate II LVAS patients, and 3) complete and sign the attached Acknowledgment Form via fax to Thoratec Regulatory Affairs at (952) 847-8571. If you have any questions, please contact 925-847-8600.
The firm initiated the recall on 01/16/15 by sending a notification letter to customers through the mail. Communication was sent to providers to contact consignees via mail return receipt to inform them of the recall. Recall notification included a Provider letter, Consumer letter, Provider Response card, Unit Disposition form and tracking sheet and the Wiring guide. The notification instructed the provider to visually inspect all potentially impacted chairs. Not all potentially impacted chairs are expected to have improperly routed and secured wires.
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
The firm, ThyssenKrupp Access sent an "IMPORTANT SAFETY AND PRODUCT USE INFORMATION" letter dated August 6, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-925-3100 ext. 5484 for assistance regarding this recall.
The recalling firm issued a Field Correction letter dated 3/9/05 to all their customers. The letter instructed the consignee on how to apply the new warning labels, to discard the old Operation Manual and replace it with the new one.
Philips Medical Systems, Inc. set a "Customer Information" letter dated July 8, 2011 to all affected customers. The letter informed them of an upcoming software updated (version 2.5). For questions please contact 800-722-9377 (option 5).
Covidien issued an Urgent Medical Device Recall letter dated January 12, 2012 to all affected customers. The letter identified the affected products, problem, and actions to be taken. Customers were instructed to immediately discontinue use of the device in thoracic surgery, Immediately advise all surgeons/surgery personnel of this recall and return products intended for thoracic use to Covidien by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers were advised to complete the Recall product return form in its entirety and return it with the returned units. For questions contact your Covidien representative or Quality Assurance at 203-492-5232.
The Firm, Ascension Orthopedics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 3, 2011 via FedEx, email or fax to all customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately cease any further use of any affected product; remove from their stockrooms until it is shipped back to Ascension Orthopedics; promptly return any affected product to: Ascension Orthopedics, 8700 Cameron Road, Austin, TX 78754, Attn: First Choice DRUJ Recall Administrator, and complete and return the reply form even if you do not have affected product in stock, to Regulatory Affairs Dept. via fax to 512-836-6933. If you have any questions, please do not hesitate to contact customer service at 1-512-836-5001.
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.
Remington Medical consignees were notified via facsimile, email and certified mail starting 02/07/2011. Distributors are requested to communicate this recall to their customers. If a customer does not respond to the recall notice within one week of the recall notification, the customer will be contacted by telephone. If this is unsuccessful, the customer will be sent a second Recall Notice letter and Customer Inventory Reconcile Fax by certified mail by 28 February 2011. If there is no response at that point, RMI will consider the customer's inventory depleted. All return product for this recall will follow RMIs Returns Goods Authorization procedure (SOP7-200). All product returns and customer responses will be documented. Upon completion of the recall, the status will be updated and submitted for the FDA's recall closure process.
Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.
An "Urgent Medical Device recall" letter dated April 13, 2009 was issued to consignees via certified mail. The letter described the affected product. and actions for customers. Consignees were instructed to carry out the recall to the retail level and to quarantine and return the product to Aspen Surgical Products, Inc. Consignees were also instructed to complete the enclosed response form and return it via mail, fax or e-mail. Direct questions about the recall by calling Aspen Surgical Products, Inc. at 1-616-698-7100, extension 142 or extension 141.
Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939. For questions regarding this recall call 574-267-8143.
A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.