mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.
The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence.
Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.
Gillette issued recall notification letters on 10/27/04 via Fed''X to Distributors and retail accounts requesting the removal and return of the devices. In addtion a Consumer letter issued 10/27/04 to provide information to the special needs and others that they are offering a replacement product for those of special needs. Gillette will post the consumer notifcation on the Gillette (Gillette.com) and Oral-B (Oral-B.com) websites.
Vascular Solutions sent an "Urgent Medical Device Recall" letter dated January 10, 2011. The letter described the issue and the product affected. Advised consignees to immediately check their inventory , place affected product in a secure location, and to complete and return the Customer Inventory Form. For questions regarding this recall call 763-656-4210.
ELITech Group of Bothell, WA sent an Urgent: Product Recall Notice dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: " Laboratories must not use plasma for the determination of total calcium when using this product. The product can still be used to determine total calcium with serum sample. " ELITech Clinical Systems SAS has revised the package insert and kit box label for the CALCIUM ARSENAZO reagent reference CALA-0250. All mentions of the use of the plasma will be removed from the documentation. If you have inventory of CALCIUM ARSENAZO, reference CALA- 0250. All lots. in your laboratory, please discard the insert that you have and replace it with the insert enclosed with this notice. " If you have transferred any of this product to another location, please forward a copy this bulletin to that location. " All users receive CALCIUM ARSENAZO, CALA-0250, from distributors. To be certain everyone who is possibly affected by this change is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached receipt confirmation to Technical Support by fax (401-642-9003) within 48 hours of receipt. We apologize for the inconvenience that this situation can cause in your laboratories; we remain at your disposal for further information. If you have any questions, please contact Technical Support at 1-855-ELITECH (855-354-324) We thank you for your cooperation and the attention which you will give to this bulletin.
Healthtronics sent an Urgent Device Recall letter dated December 20, 2012, to all affected customers that allows tracking. The letter included a suggested format/content for a correction status/acknowledgement letter. The customer was requested to complete the verification section of the recall letter and return all affected products to Healthtronics. A return material authorization (RMA) and pre-paid FedEx return labels was provided for all customers. All affected Healthtronics field personnell were notified of the recall via email. For questions regarding this recall call 512-439-8355.
Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.
Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.
Siemens sent an Urgent Device Recall letter dated April 2012 via fax to affected U.S. customers and an Urgent Field Safety Notice to customers outside the U.S. The letter identified the affected kit lots, reason for voluntary recall, risk to health and actions to be taken by the customer/user. Customers were instructed to discard any inventory of the affected kit lots and complete and return the attached Field Correction Effectiveness Check questionnaire within thirty (30) days to request a no-charge replacement kits. Customers were requested to post this field correction by each IMMULITE system to alert users to the situation. For questions contact your Siemens Technical Solutions Center.
Capintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer. Customers can contact Capintec concerning this recall at 201 825-9500.
Consignees were notified via a Urgent Medical Device Notification letter/customer letter sent out on 9/25/2007 under Siemens update program US013/07/S. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. Consignees who do not respond to the recall communication will be visit ed and/or telephoned for follow up.
The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned.
Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to CorporateQuality.Postmarket@zimmer.com within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts. For questions regarding this recall call 574-372-4807.
The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table. For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634.
AngioDynamics sent an URGENT: Medical Device Recall letters and response form (dated November 10, 2011) to all affected customers. The letter identified the affected products, the problem, and the actions to be taken by customer/user. The customers were instructed to do the following: 1) Identify, segregate and return the recalled products to ANGIODYNAMICS and 2) Complete the enclosed Recall Reply Form even if they do not have any products remaining in their possession, noting zero quantity to be returned and fax to 518-798-1360. The letter states that a returned authorization number (RA#) will be assigned to each customer in the recall notification letter, an UPS account will be provided for return freight and a replacement product will be shipped upon receipt and confirmation of the returned product. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to customerservice@angiodynamics.com.
Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.
Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.
Siemens Healthcare Diagnostics Inc. sent a Urgent Device Recall letter to all affected customers dated May 2012. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers to immediately discontinue use of the device, quarantine and dispose of all inventory, ensure that your Medical Director reviews this letter as well as the attached physician letter. Please complete the attached Field Correction form and fax to 302-631-8467. Further questions please call 302-631-6311.
Consignees were notified of recall by certified mail, Urgent Device Recall letter dated 11/21/2007, which was sent to each consignee. The recalled product will be returned to the firm by pre-paid FedEX return labels. A second letter is to be issued to each distributor for recall to the retail level, as the firm's original recall strategy of distributor level recall, was deemed inappropriate by CDRH
Terumo sent an URGENT MEDICAL DEVICE REMOVAL notification letter dated November 10, 2011 to all affected customers. The letter described the affected products, problem, potential hazards, and important clinical information. Replacement roller pumps will be configured at the customer site by a Terumo Field representative with the affected roller pumps being returned via normal returned goods process. Customers were asked to complete the attached response form and fax to the number indicated on the form. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818.
Hospira sent an URGENT MEDICAL DEVICE CORRECTION letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included the following instructions: 1) To avoid failure to power up, turn the pump on first, before connecting the pump with the docking station. This will prevent the failure to power up. 2) To mitigate the potential for an 11/003 error code, remove the External Battery Pack accessory (List 13073) from the Docking Station in conjunction with an External Battery Pack accessory (List 13073), this practice should not continue. Please contact Hospira to discuss an appropriate alternative. Additional instructions included: 1) Inform potential users within the recipient's organization of the notification. 2) Should the facility experience a failure to power up or an 11/003 error code, report the issue to Hospira by calling 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CT) or e-mail ProductComplaintsPP@hospira.com. 3) Compelte the attached reply form and return it to the fax number or e-mail address on the firm, even if there is no affected product in inventory. 4) If th products were further distributed, notify the accounts that received the products identified in the notification and ask them to contact Steriycle at 866-792-5451 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. For questions regarding this recall call 800-441-4100.
MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Lumitex, Inc. issued a recall letter dated July 2, 2009 to their Customers describing the affected device and requesting its return. For further information, contact Lumitex, Inc. at 1-440-243-8401.
Recall letters dated 12/15/03 were issued to receiving hospitals. Hospitals were instructed to cease implantation, quarantine stocks, and to notify implanting physicians to monitor their patients.
A Recall Notice, dated 05/28/05, was sent to Risk Managers. The notice informed them of the issue and instructed them to discontinue use and segregate affected units. A Tracking/verification Form is requested to be returned. Arrangements will be made for returning affected product.
Stille sent Field Safety Notices dated 8/27/08 to the direct accounts, informing them that the table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically will supply continuous power to the control box. The accounts were requested to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 9/26/08. The accounts were advised to not further use the table in conjunction with a C-arm or any other heavy object until a service technician can permanently remove the battery from the control box according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction to the table once it has been validated and approved. Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.
All affected Smith & Nephew Sales Representatives were notified of problem and the recall via email on 5/29. They were instructed to cease use and distribution of the product and quarantine for return. Surgeons were notified by letter beginning on 6/12. International consignees were notified on 05/29 via email.
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
STERIS sent an Urgent Voluntary Field Correction Noticel letter dated June 27, 2014 to affected Customers.via FedEx with tracking numbers for delivery confirmation. The letter identified the description of the product, description of the problem and the actions to be taken. For questions contact Steris Field Service Dispatch at 1-800-333-8828.
A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate adn detach from the devices. Consumers are instructed to report any adverse reactions or quality problems experienced with the use of the product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Consumers with may also contact Covidien Customer Service at (800) 716-6700 between 7am to 7pm (central) or email at customerserviceus@covidien.com.
An AGA Medical Product Recall Notice, dated December 18, 2009 was sent to customers on 12/18/2009. The letter identified the affected product, described the issue and asked for devices to be returned. Customers are asked to complete a form attached to the product recall notice and return it to AGA via fax or email.
Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.
The firm, Carestream Health Inc., sent an "Urgent: Medical Device Recall" letter dated August 29, 2013 to its customers. The letter described the product, problem and actions taken. Carestream has developed a software patch that will allow Normal Exposure Mode and Extended Exposure Mode images to be taken in any order and will install the patch in all DRX-Revolution, DRC-Mobile and DRX-Transportable Systems with software version 5.5 or higher and Detector firmware version 69 or higher. No DRX Transportables were affected. Your Carestream service representative will install the patch at your next service call. If you have questions or concerns, or if you experience an issue prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8am through 8pm Eastern Standard Time.
On November 19, 2014, Philips notified consignees of the recall via letter. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice
Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
Teleflex Medical sent an "Urgent Medical Device Recall" letter dated July 30, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to immediately discontinue use, quarantine any affected products and return all of the affected product to Teleflex Medical; forward the letter to their customers to retrieve product from those locations and complete and return the Recall Acknowledgement Form via fax at 1-866-804-9881. A second mailing to non-responding customers on the consignee list will be mailed approximately four to six seeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. Note: A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
An "URGENT - Field Safety Notice" dated April 27, 2009 was sent to all consignees via certified mail. The letter described the affected products, issue, and actions for the customer/user. The notification letter provides a work around until the new software is available. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.
The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.