mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
BD Diagnostic Systems verbally notified all affect customers via the telephone on March 28, 2011. The notification identified the product, the problem, and the action to be taken by the customer. An "URGENT PRODUCT RECALL" follow-up letter was mailed to all customers on April 8, 2011 via UPS. Customers were instructed to complete and fax the attached reply form to acknowledge their receipt of the notification to Regulatory Compliance, 410-316-4256. The letter instructs customers to refer to the modified release notes and IMPORTANT NOTICES outlined in the attached notification letter. If further assistance is needed regarding replacements and all other inquires, please contact BD Technical Services and Support at 1-800-638-8663.
Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460.
Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.
Customers were notified via urgent product recall letter dated March 16, 2005, to return the product for replacement.
An initial phone call was placed to expedite return and replacement of product. A follow-up letter was sent. The initial phone calls to customers began on November 1, 2005.
Smith & Nephew sales representatives and Smith & Nephew international distributors were notified of problem and the recall via email on February 7, 2013. They were instructed to cease use and distribution of the product and quarantine for return. Non responding consignees were notified again on February 28, 2013 by email. Hospitals were notified by letter beginning on February 7, 2013. Smith & Nephew also contacted the surgeons who implanted the screws by letter the week of February 11th. For questions regarding this recall call 978-749-1330.
Consignees were sent a Medtronic "Urgent Medical Device Correction" letter dated April 2014. The letter was addressed to Risk Manger, Health Care Professional. The letter included the Issue Description, Root Cause, Potentially Affected 5348 EPGs within the Serial Number Ranges, Malfunction Indications, and Recommended Actions. For questions related to EPG service policy or purchasing a replacement EPG, customers should contact your Medtronic representative. For technical questions, please call Instruments Technical Service at (1-800)638-1991. Medtronic asks that customers complete and sign the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or e-mail to RS.CFOFCA@Medtrnic.com.
Liko North America ,the US Distributor, notified accounts by letter dated June 30, 2008 and provided a Field Safety Notice with Safety Inspection Procedures to performed on the lift prior to use. Replacement slingbars are being provided. If you have questions, contact the Liko product distributor in your country. Contact information can be found at www.liko.com/int/distributors.asp.
The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.
Roche issued Product Advisory Notice (PAN) 2012-11 and Urgent Field Safety Notice PAN 2012-11 by email to Local Safety Officers (LSO) and General/Country Managers from all countries on 28-Nov-2012. The notice identifed the affected product, problem and actions to be taken. LSOs are to provide the information in the Field Safety Notice (FSN) to each customer and return a Feedback Form to Roche (email address: rmdsafeb@roche.com) once actions in FSN are executed.
INTEGRA sent an Urgent Medical Device Correction Notice dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to identify members of surgical team that ues the affected product and make them aware of the Medical Device Correction Notice. Customers were asked to sign and return the enclosed Medical Device Correction Notice Acknowledgement and Return Form and to maintain a copy of the notification and signed copy of the acknowledgment form for their records. For any questions regarding this recall call 609-936-6832..
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.
Civco Medical Instruments Inc sent a FIELD SAFETY NOTIFICATION letter dated October 28, 2013 via UPS to their customers. The notification identified the affected device, problem, and field safety corrective action. The letter describes how customers can check to see whether the scales on their device are out of alignment. The letter states CIVCO will rework the system to correct the difference. For questions contact sales representative at CIVCO Medical Solutions, Radiation Oncology at 800-842-8688 or 712-737-8688.
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
Cholestech provided its three distributors a notification letter/response form with instructions to distribute the letter to their customers/end users dated August 9, 2006. The letter instructed customers to discontinue use of the lot of cassettes, return remaining cassettes to Cholestech through the Technical Service Representative and to complete and return the response form. The end users returned the signed letters directly to Cholestech so that effectiveness checks could be completed.
Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.
ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.
Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.
Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¿ II and Flexicair¿ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¿ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
Telephone calls were initiated to the direct accounts on 2/15/05 and by letter initiated 2/21/05 requesting return of the product and subrecall by the direct account, unless the direct account preferred the recalling firm to conduct the subaccount recall. The recall was later expanded and recall letters dated 4/29/05 were issued requesting the same information as the initial letter.
The firm initiated their recall to their sales representatives (distributors) via telephone on 06/07/2010 and followed with a letter dated June 15, 2010 sent via Fed Ex on 06/28/2010. The hospital involved was also notified by letter on 06/29/2010. The letter described the product, the problem,and the action to be taken by the customers. The customers were instructed to immediately return any affected product to Wright as soon as possible, and to complete an attached response form confirming receipt of the notice and return a copy by fax to 901-867-7401. Customers may contact customer service for return instructions and replacement inventory at 800-238-7117. If you have any questions regarding this matter, contact Debby Daurer at 800-874-5630.
Philips sent an Urgent Medical Device Correction letter dated July 20, 2016 to all affected customers. The 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. Customers were informed that Philips will provide a software correction free of charge. For any further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377.
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Recall notification was faxed and/or e-mailed to consignees on 09/29/08 and then sent via mail on 09/30/08. A follow-up response form was faxed to consignees starting 10/01/08. Consignees asked to return product for a credit. For additional information, contact Rockwell Medical Technologies, Inc., Customer Service at 1-800-449-3353.
The firm mailed a recall letter to there consignees on June 30, 2003 requesting return of any unused devices. The firm has received 100% response and accounted for all recalled devices.
A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concerning this issue, please contact the Neusoft Medical Systems Service Support Department (helpdesk@pnms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.
The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.
Covidien sent An Urgent Product Recall letter, dated February 9, 2012, to all affected consignees. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product if found. The letter asked customers to fill in teh quantity remaining in their inventory and fax it to 651-565-5888. A Covidien Customer Service rep would contact the consignee for returning product. Consignees were also requested to notify their customers of the recall. For questions regarding this recall call 508-261-8532.
Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000.
Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.
On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: LTSD@kingsystem.com.
An Urgent - Product Safety Notice customer letter was sent via FED EX on 2/6/12 and 2/6/12 to direct consignees in the US identifying the affected product and the issue with it. The letter states that Medtronic Navigation is removing the product from clinical use and will provide a sales credit to customers. In the letters to Medtronic field personnel, it states that local sales and service personnel will be identified to remove the affected product from customer sites and return them for scrapping. Customers are to contact a sales representative if they have any questions regarding the letter.
On 8/7/2014, Zimmer notified all distributors via electronic mail. Distributors that have received affected inventory are also notified via courier. Hospital risk managers and surgeons are also notified via courier. Hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons.
On December 22, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to examine their inventory immediately to determine if they have any of the affected serial numbers. If you have an affected system running on software version 4.8.0 through 4.8.3, you may continue use of the device until the software is updated with the following considerations: 1. If during use, the device is switched from Automatic to Manual and it is found that the manual bag is empty the user can activate the Emergency ventilation or turn off/on the device to reset the disabled valves function. 2. Users may also use the resuscitator that is available in the Operating Room. Getinge will update the software to correct the issue free of charge. You can arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Recall letters were issued to the US customers by Biomeriux, Durham, NC on 9/6/2013.
Richard Allan Scientific (RAS) initiated a voluntary recall of Mucolexx and Mucolytic Agent due to fungal contamination on 5/1/2015 via certified mail to all customers who received the affected. Customers were asked to return a repsonse form, and dispose or return all recalled products. Please contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher
On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.
Philips Respironics has determined that affected devices may continue to be used in accordance with the device Instructions for Use and the Field Safety Notification that is being issued to customers. Philips Respironics will be providing a software update for affected devices free of charge. Customers will be notified by mail when the software update is available for download. For further questions please call ( 724 ) 387-7500.
U.S. and foreign consignees were notified via letter dated 12/20/05 and requested to return stocks on hand. Distributors were requested to notify their customers.
An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.
Orthofix sent an Urgent Medical Device Product Advisory Notification letter dated May 11, 2015, to the affected distributors and hospitals. The consignees were directed to inspect thier inventory and perform checks before surgical use of the drill guides. Customers were instructed to provide a copy of the Product Advisory Notification letter if product was further distributed. Customers with questions were instructed to contact their local Orthofix representative and to for returns they should contact Orthofix customer service representative at 888-298-5700.
A customer communication was sent by first class mail on 7/26/05, advising all consignees of the problem. The letter asks each customer to immediately examine their inventory for affected lot numbers, return product from affected lots using enclosed label and packing slip, and to notify all of their affected customers to alert them to the situation.
Consignees were notified via an Important Market Withdrawal Letter sent 2/25/05. The letter instructed users to fax a Product Accountability Form to the recalling firm identifying any affected products and to return them to the firm. The letter informed users that the products will be reworked and returned at a later date. The letter also identified other products that could be used as replacements. For additional information, contact 201-831-5825 or 201-831-5110.
A recall letter, dated August 6, 2014, was sent via email which identified the product, problem, and actions to be taken.