mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Zimmer sent an Urgent Device Removal letter dated February 14, 2013, to all affected consignees. The letter identified the product, the problem,and the action to be taken by the consignee. Consignees were advised to review the notification letter, follow the instructions contained in the letter, remove from use and quarantine the affected product. Consignees were also instructed to complete and return the fax back from to 877-787-0375 or zimmer3632@stericycle.com. Consignees were instructed to return the affected product back using the shipping label provided. If affected product was further distribution, consignees were asked to provide the customer's information to the firm on the back of the form. For questions regarding this recall call 866-201-9081.
The firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069. If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.
Phone calls and faxed notification forms were sent to all customers on June 4, 2004. Outside the US, subsidiaries were notified via e-mail with forms to be completed.
Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com
On April 13, 2020, the firm distributed URGENT Medical Device Recall letters to affected customers. Customers were informed of the device defect, which may result in the following unexpected behavior: - The device may not turn on. - The device may not perform the selected function. - The device may deliver a shock with an energy level different from the setting selected by the user. There have been three reported patient deaths potentially associated with the failure of the HeartStart XL Monitor/Defibrillator rotary therapy selector switch. Customers were advised that the HeartStart XL Defibrillator/Monitor has been discontinued and has reached its end of life. Therefore, custoemrs should replace and retire their units as soon as practically possible. Customers should continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure until your units are safely retired. If you identify a device that exhibits any of the behaviors described above, or which fails shift or operational checks, immediately remove it from service. Customers were asked to complete and fax or email the included customer reply form to Philips. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377.
Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved.
All affected Smith & Nephew Sales Representatives were notified of problem and the recall via certified letter and e-mail on 4-22-08. All affected Smith & Nephew International Distributors were notified via email on 4-22-08 and 4-23-08. They were instructed to immediately notify their accounts concerning the recall. If you have questions, contact Customer Service at 800-238-7538.
Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.
Two letters "GE Product Safety Notification" dated 12/18/07 and 3/7/08, addressed to Hospital Administrators, Manager of Radiology and Radiologists, were sent to each consignee. Each letter addressed a separate safety issue. Letters described the affected product, safety instructions, corrective action and contact information. The joystick can become stuck causing unintentional motion of the tube. Field Modification Instructions (FMI 10802/10803) have been issued to the field to install additional warning labels on the patient table, install a protector for the console joystick and inspect and correct the clearance between the console joystick and its mounting location. If your facility has a Precision RXi or Precision e system manufactured before March 2007, a GE Healthcare Field Engineer will schedule a field visit to install the added joystick protection. This upgrade will be performed at no charge. If you have any questions/concerns regarding this issue, please contact your local GE Healthcare sales or service representative.
BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.
An urgent device correction letter dated 12/16/02 was sent to each customer. The letter advised of the problem and instructed customers to follow a strict quality control regime to ensure proper electrode performance. Customers were instructed how to automatically lock the affected parameter so that patient results will not be reported if QC performance violates the customer''s programmed rules.
The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.
PerkinElmer sent an Urgent Medical Device Recall letter on July 1, 2014, to all affected customers. The letter informed customers of the recall and provided instructions. Customers were asked to complete the enclosed response form and fax it to 1-330-825-8520. For additional information, customers were instructed to contact their local PerkinElmer representative or email specimen.gate.support@perkinelmer.com. Customers with questions were instructed to call 1-800-321-9632. option 1.
Ansell HealthCare Product LLC sent an Recall letter dated January 14, 2013, via registered mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification informs customers about the problem with the affected product and provides instructions to the customers on how to handle affected product. Customers are asked to complete the Response Form and return via fax (1-800) 722-8155. If you have further questions, please contact our Customer Service Department at 1-800-952-9916.
On 8/2/2012 an URGENT PRODUCT CORRECTION INFORMATION FOR PHADIA VARELISA CARDIOLIPIN IGM, Article Number 15696 letter was sent to all consignees the received the Direction for Use modification letter in 2004.
Customers were notified by letter and phone during 10/20/2008 and 10/29/2008 to schedule visits by Paramed to correct the devices.
EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the user's EOS system. This should be completed by the end of calendar year 2012. Your proposed CAP appears to adequately address the issues you raised in your notification, and is hereby approved. Your proposed customer notification letter as revised, appears to adequately provide instructions with respect to the use of the product pending the correction of the defect and it appears to provide a clear evaluation in nontechnical terms of the potential hazards related to the defect. Your proposed notification letter is hereby approved for distribution to all affected parties. Further questions please call 678-564-5400.
Medtronic mailed an "Urgent Medical Device Correction " letter addressed to Dear Healthcare Professional on March 12, 2012. The letter described the problem, Background, Clinical Manifestations, Recommendations, and Additional Information. To ensure there is no interruption in therapy, pump replacements should be scheduled before the ERI alarm sounds and the pump reaches its 7-year end of service. Customers were advised to forward the Urgent Medical Device Correction letter to patients whose name appears on their Pump Replacement List. Reimbursement SupportFor assistance with prior authorization, contact Medtronic Reimbursement at the numbers below: Therapy for Severe Spasticity: (800) 292-2903 Pain Therapies: (866) 962-9909 For questions regarding the letter call 800-328-0810.
Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. .
Ormco sent an Urgent Medical Device Recall letter dated March 8, 2013 to all affected customers, via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees were instructed to complete the Return Form and return any affected product identified in stock. For questions contact Ormco Customer Care.
The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.
Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated July 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgement Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for assistance with this recall.
Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers. The firm does not intend to continue manufacturing or distributing the product.
Boston Scientific/Microvasive, Natick, MA initiated a voluntary recall by letter dated 1/27/03, and mailed 1/29/03. Accounts were requested to remove affected lots and return product to Boston Scientific. A verification form was provided to monitor effectiveness of the recall notification. Non-reponders will be recontacted.
Baxter sent an Urgent Device Correction letter dated December 4, 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 check the patient order against the final bag label as part of the TPN acceptance procedure to ensure that the patient's TPN order is correct. Customers will be contacted by Baxter to arrange for installation of a software upgrade specific to their compounder's configuation. Customers were asked to acknowledge the receipt of this notification by completing the attached Customer Reply Form and return it to Baxter by fax to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. If the product was distributed to other facilities customers were instructed to notify end-user customers in accordance with their customary procedures. Customers with questions were instructed to call 1-800-678-2292. For questions regarding this recall call 800-422-9837.
Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.
Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.
BrainLab send a A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 15, 2013, to all affected customers. The letter requested that customers verify that they are in possession of one or more of the affected devices, remove the affected devices from use, and that Brainlab will provide replacement parts for the customers. Customers with questions can contact Brainlab by telephone at 1-800-597-5911 or via e-mail at us.support@brainlab.com. For questions regarding this recall call 800-597-5911.
DePuy sent an "URGENT RECALL INFORMATION-FIELD SAFETY NOTICE" letter dated May 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 574-372-7333 for questions regarding this notice.
On 2/6/06 the firm sent a Product Safety Notification letter to the customers that have devices installed. The letter advises of the problem, and to restart the device if it locks up. The letter also states that the firm will be performing upgrades of the devices.
The firm, Terumo, interviewed the Sr. Product Manager from the Marketing Department of the company on August 29, 2012. The interview included the description of the product, problem and action taken. Replacement connectors were provided to users and all units were corrected. If you have any questions, call 734-663-4145 or Manager, Regulatory Affairs at 734-741-5576.
Boston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account 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. For questions regarding this recall call 508-382-9555.
Stryker sent an Urgent Urgent Recall noitifications letter dated May 7, 2013 via certified US mail and E-mail l to all affected customers, distributors and direct accounts. The letter identified the affected products, problem, risk to health, and actions to be taken. Customers were instructed to check inventory, immediately quarantine any affected product, and open each package before discarding to prevent use. Customers were directed to fill out and return a Business Reply Form to Stericycle, Phone: 888-943-2396 Fax: 888-943-4192, Email: stryker5893@stericycle.com verifying directions and confirming recalled product was destroyed. For questions call 269-389-4354 or 269-389-4518.
The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm representative.
Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .
Siemens Healthcare Urgent Medical Device Correction (UMDC) was mailed to all affected Siemens Healthcare Diagnostics customers in the United States on April 11, 2014 for customer receipt on April 14, 2014. This notice informed the customers of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra and Vitamin D Total assays. This notice instructs customers that the TSH3-Ultra and Vitamin D assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facility's laboratory or medical director. B. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on April 10, 2014. This notice informed the customer of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra , Vitamin D Total and ADVIA Centaur BRAHMS Procalcitonin assays. This notice instructs customers that the TSH3-Ultra, Vitamin D and Procalcitonin assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facilitys laboratory or medical director. (Note: The ADVIA Centaur BRAHMS Procalcitonin assay is not sold in the US.)
A User Notice was sent by the firm to its consignees. It identified the affected product and the reason for the recall. It also discussed the clinical impact and interim mitigations. The firm states in the letter that a fix for the problem and been developed and is available. Customers are to contact IMPAC Support for the patch to the SL75-5 interface. If customers have questions, concerns, or requests, they can email support@impac.com or one of the numbers listed in the letter for the applicable country. The letter should be distributed to all users affected by the issue at the customer's organization.
The consignee in Germany was notified by an Urgent: Device Recall letter dated 1/29/09, and delivered by email on 2/19/09. The letter stated the reason for the recall and clinical implications. The firm asked the consignee to stop using the provisional and quarantine it immediately; physically count all affected product and record data on the Inventory Return Certification Form included with letter; fax a copy of the completed form to Zimmer, Inc at 574-371-8603; request an IRA from Lindsey Arnett; and return recalled product along with completed Inventory Return Certification Form and IRA to Simmer Distribution Center. The letter states that credit will be issued upon receipt of the returned product. Also, if product has been further distributed, a copy of the recall letter should be provided to the customers. Questions or assistance should be directed to Zimmer, Inc at 1-800-613-6131.
Breg representatives informed customers of the recall by telephone on March 14, 2014 and then a customer notification letter was sent to customers via email onMarch 17, 2014. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the return response form. Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607.
An "Urgent Device Recall" letter dated 8/20/2012 was sent to all customers who purchased the Armada 35 and Armada 35 LL PTA Catheters. The letter informed the customers of the problem identified and the action to be taken. A list of lot numbers and an effectiveness check form was sent to customers with the customer notification letter. Customers were instructed to call Abbott Vascular Customer Service at (800) 227-9902.
This recall has been completed. Recall notice was sent by fax on October 25, 2002.
On 04/17/24, correction notices were emailed to consignees who were asked to do the following: 1) If you experience the described uncontrolled motion, stop using the device and contact your service provider to have your device repaired. 2) The correction notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 3) Complete and return the response form to either support@nrtxray.com or servicesupport@alpha-imaging.com A firmware update will be made to all motor controllers in the system. The update will be performed by the Service Provider. Customers with recall-related questions can call 1-800-331-7327.
The firm notified their consignees by letter on 1/13/15, sent via FedEx. The US customers were instructed to return any remaining product to MED-LOGICS and complete the response form.
The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.
Recall notice was sent by fax March 27, 2003. The recall is complete.
The firm verbally contacted each distributor on September 10, 2014 to notify them about the recall and actions that needs to be taken.
Kurz Medical, Inc. sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated May 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to return unused product for replacement by using an enclosed FedEx label. If the product has been implanted , the letter requests the customers send the date of surgery and size of the implant.
The mislabeled catheter was returned to Spectranetics. The second possible mislabeled catheter was visually inspected by a Spectranetics representative and confirmed the catheter was labeled correctly.
The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.
The recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.