mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached "Product Removal Acknowledgement" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. If consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at (800) 227-2862 to arrange for return. Canadian customers may call (800) 624-2920. International customers may call (610) 691-5400. A Customer Support Representative will provide consignees with instructions for handling the affected product. The firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the consignees facility. Consignees were informed that B. Braun is currently working to resolve this issue and provide an acceptable alternative to the market. They expect this product to be available in August 2010. In the interim, B. Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use. If customers have additional questions regarding with a matter, they are to call B. Braun Customer Support Department at the number listed above. Should consignees identify product where this condition has occurred, consignees were asked to report it promptly to B. Braun Medical Inc. by contacting the B. Braun Clinical and Technical support at 1-800-854-6851.
Teleflex Medical sent an URGENT FIELD SAFETY NOTICE dated January 4, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for product, cease use and distribution of stock from the affected lot number and quarantine all products from the affected lot number immediately. Customers were instructed to complete the field safety corrective action acknowledgement and stock status form and fax to their local Teleflex Medical Customer Service Sales Rep. If the customers did have stock from the affected lot number, they were to contact their local Teleflex Medical Customer Service/Sales Rep or distributor as indicated on the attached field safety corrective action acknowledgement and stock status form for a Return Autorization Number. Distributors were to communicate the field safety corrective action notice to their customers and forward the completed Acknoweldgement Form to orders.intl@teleflexmedical.com or fax to +353 1 437 0773. For questions regarding this recall call +353 906 460 838
The firm, Technidata, sent an "P1 DEFECT INFORMATION" notice dated July 2, 2010 to their consignee/customers. The notice describes the product, problem and actions to be taken. The notice directs them to find the correction to the software issue on the Technidata website where they are able to install the correction kit depending on the version and operating system used. Note "You must back up the database and the installation directory before installing this correction". Should you need any further information, do not hesitate to contact the Support team at +33 (0) 4 76 04 13 00.
The firm retrieved the 6 devices from the consignees identified, following a telephone request on 1/18/2006. The firm does not consider this a recall.
Cardinal Health sent separate recall letters dated 9/27/06 via UPS next day delivery to those accounts who ordered the drapes alone and those accounts who ordered custom sterile packs and PBDS modules, informing them that the cardiovascular split drapes may tear and/or fray at the reinforced fenestrated trough area during use. The letters listed the catalog numbers and affected lot numbers of the sterile drapes, and the letters sent to the pack and module customers were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to inspect their inventory to determine if they had any of the affected product on hand; segregate the affected inventories; complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of drapes in inventory being destroyed; and contact the El Paso Customer Service Center at 915-779-3681 to order replacement product. Distributors were requested to notify their customers of the recall. An additional letter dated 10/25/06 was sent via UPS overnight delivery to 49 of the accounts, expanding the recall to include lot 06HRD110 of catalog #9158, Convertors Tiburon Cardiovascular Split Drape II, Sterile. The instructions remained the same as those in the 9/27/06 letter.
An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock.
The firm, Zimmer, made telephone calls using a phone script document entitled "Urgent: Medical Device Recall" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect. If you have any questions, please call (574) 371-8852.
Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.
Siemens sent a Customer Safety Advisory Notice dated April 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our service organization already checked all syngo Imaging sites and did not find any other occurrence of the wrongly configured link. Additionally our service organization will include the check for such wrongly configured links into the existing proactive site monitoring procedures. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please include this safety advisory notice in your operator's manual. In the interests of safety, we ask that you perform the above preventive measures and inform all affected personnel immediately. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (610) 219-6300. .
Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.
Ortho Development Corporation notified Field representatives of the issue and conditions that could lead to failure by e-mail on December 14, 2010. Redesigned product is being produced for replacement. For questions regarding this recall call 801-619-3450.
The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, were recalled by letter dated 5/30/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the IMx kit, and were requested to discontinue use and destroy the affected lots of product. Abbott sent a Device Correction letter dated 6/4/03 to those accounts receiving the Architect Free T4 Calibrator kits, informing them of the problems experienced with the The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, made from the same raw material. The accounts were informed that the Architect Calibrator was performing as expected, but as a precaution recommended conducting a daily QC with non-Abbott Controls and to report back to Abbott any out of range non-Abbott control results.
An "Urgent-Product Recall Notification" letter dated March 23, 2009 was issued to consignees. The letter described the issue and instructed customers to examine their inventory immediately to determine whether they have any NL950V - Ventrix Ventricular Tunneling Pressure Monitoring Kits, or NL950VC - Ventrix Ventricular Tunneling Pressure Monitoring Kits with Ventricular Drainage System. Customers were further instructed not to use the above recalled product. Call Integra Customer Service at 1-800-654-2873, and then select 5 for 'Returns and Repairs' to obtain a Returned Material Authorization number, and return the product as directed. Direct questions about the recall to Integra NeuroSciences by calling 1-858-455-1115, extension185.
A customer notification letter dated 5/7/15 will be sent to all customers on 5/13/15 to inform them that ASP is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels and subsequently pass the cycle without cancellation if there is a disconnected scope. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle: 888-879-8144. Customers with questions regarding the business reply card are instructed to contact Stericycle at 888-345-4671 and reference event #7781.
Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated January 18, 2010, to all affected customers. The letter provided the customer with an explanation of the problem identified, the affected product, and instructions for the customer. The letter requested customers complete the following actions for : (1) CTA Aliquot Probe Inspection and Maintenance: a. Check daily for signs of leaks or damage to the tube fitting by looking and feeling for liquid at the fitting, the end of the probe and the surrounding areas; b. The CTA Aliquot Probe tube fitting should be checked to ensure that it is connected tightly to the Aliquot Probe. Without loosening the tube fitting, ensure it is securely tightened; c. When replacing the CTA Aliquot Probe, ensure that the Aliquot Probe tube fitting is securely tightened, prime the CTA, inspect for leaks, and run Access Quality Control through the CTA; d. If a leaking Aliquot Probe is suspected, review all sample results for both Access and Synchron in light of the total clinical presentation of the patient including: symptoms, clinical history, data from additional tests, and other appropriate information; e. As this issue may result in dilution of the sample with Wash Buffer; it may be appropriate to discard and redraw any affected sample tubes run on the CTA. The letter also informed customers that Beckman Coulter is currently evaluating potential solutions for this issue and requested they share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected products to another laboratory, they were asked to provide a copy of this letter to them. They were also instructed to complete and return the enclosed response form within 10 days. Customers were told to call Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada with any questions.
Urgent Device Correction Letters were sent to all sites affected by the retrofit on September 12, 2011 via Fed Ex. The letter identified the affected product and the description of the potential problem. Customers were asked to inspect their Synchrony System by following the instructions provided. If the lower extension feels loose, customers should contact Accuray Customer Support immediately to schedule service of the system. The letter also states that all affected systems will be inspected and corrected, if necessary by Accuray to prevent the potential problem. Accuray Customer Support will contact customers to schedule the inspection. Questions or concerns regarding the issue should be directed to Accuray Customer Support at 1-877-8667 for US customers and 1-408-716-4700 for customers outside of the US, or customersupport@accuray.com.
Abbott sent an Product Recall letter dated September 11, 2014, to all direct accounts (customers). The letters included instructions for customers to: 1) Discontinue use of and destroy any remaining inventory according to your laboratory procedures; 2) follow your laboratory protocol regarding the need for review of previously reported patient results; 3) replacement material is available; for ordering, please order through your normal ordering process; and, 4) if you have forwarded any of the affected lots to another laboratory, please provide them with a copy of this communication. Customers or healthcare providers with questions can contact Customer Service at 1-877-422-2688 (24 hours a day, 7 days a week).
Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.
Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product. Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378. If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to: RGA Department Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095-2416 For any questions regarding this recall call 801-316-4822 or 801-208-4365.
The firm issued and Urgent Electronic Device Recall letter dated September 9, 2022. Please complete and return the Electronic Device Recall Return Response form below as soon as possible to acknowledge receipt of this letter and initiate the process of sending back your UVILIZER Flip (Model Seago SG-153).
Lumenis Limited sent an Urgent Safety Advisory Notice dated March 25, 2015, to all affected customers. Customers were instructed that Lumenis is eliminating the potential risk of patient harm through a software upgrade and Operator Manual replacement. The software upgrade must be completed by a Lumenis-certified engineer as soon as possible. In the Interim, customers can continue to use their LightSheer DESIRE system by following the recommendations in the operator manual to always perform a test patch prior to a full treatment. Customers with questions were instructed to contact the Aesthetic Business Unit Product Manager. For questions regarding this recall call 801-656-2690.
Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.
Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.
CooperSurgical initiated the recall on May 18, 2015 via Fedex with confirmed delivery receipt. The letter identified the affected product and asked users to discontinue use and complete the Acknowledgement and Receipt Form to schedule a replacement. Questions contact 203.601.5200.
Axiobionics, LLC is notifying all affected customers by phone. Three attempts will be made to contact the customer by phone. Contact by telephone will be made to prescribing physician to determine if Axiobionics has latest patient contact information. If information is different, new contact information will be recorded and 3 additional attempts will be made with the new information. If the patient cannot be reached by telephone, a certified letter will be sent to the patient's address. If contacting by mail, the letter template will be provided to the FDA recall office . All patients should have been contacted by telephone, certified mail, or in person by June 10, 2011. All patients affected by the field correction will be asked the following questions to determine if their electrodes are functional and resistances are not exceeding the output capabilities of the stimulator they are using. 1. Are you using your garment? 2. Is your garment delivering the stimulation required for your therapy? 3. If the patient is using an NP4 stimulator: What are the resistance readings on each channel? 4. If the patient answers No to question 2 or states that the resistance is reading greater than 200 ohms on at least one channel in question 3, the garments will be returned to Axiobionics for repair. Garments that are not functioning correctly will be repaired first. Functioning garments will be tested by immersion into a salt bath under the given protocol to determine if the silver fabric is properly coated. Questions regarding this correction should be directed to the Axiobionics representative at 800-552-3539.
All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit.
PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.
This is a retrospective report for the March 2021 Technical Bulletin, which described a Product Update; specifically the AIC Version 8.5 Software Update. The software update began rollout on March 4, 2021. According to the firm, Version 8.5 of the software contained bug fixes for the issues seen in version 8.4. The technical bulletin was posted to HeartRecovery.com on March 5, 2021.
Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 extension 3173
Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
Extremity Medical sent an e-mail notification (Extremity Medical- Sales Bulletin- IO Fix) dated April 13, 2011 to distributors notifying them of a change made to the 4.0 mm Lag Screw.
Consignees were sent on 4/29/10 a GE Healthcare "Urgent Medical Device Correction" letter dated 4/22/10. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering, and Home Healthcare Provider. The letter included the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information.
An Urgent Medical Device Field Correction letter, dated 3/22/13, was sent to customers who purchased the EVOTECH Endoscope Cleaner and Reprocessor (ECR) HIPOT Testing. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed on what to do if electrical shock occurs. Customers are instructed that they will be contacted in the next 2 weeks on behalf of ASP to schedule HIPOT testing. Customers with questions are instructed to contact Stericycle at (888) 965-5816. Customers are instructed to report complaints or suspected problems with their EVOTECH ECR system by contacting ASP Professional Services directly at (888) 783-7723 and select option #2.
The firm, Radiometer, sent two "Priority Level: Urgent" letters one dated July 9, 2012 and the other dated July 24, 2012 to its affected customers via FedEx with tracking. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the attached Recall Response Fax Form via fax to 800-736-0601. The letter informed the customers that a local service representative will be contacting them shortly to install a software update that will prevent this from occuring (in the event that you utilize HL7 version 2.5 or intend to at some future date.) If you have any questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt. 4.
The firm, RaySearch Laboratories, sent an "Urgent Field Safety Notice, Medical Device Correction" letter dated May 9, 2012 to its customers. The letter describes the product, problem and actions to be taken. The letter informed the customers that the "workaround is to not use segment MU optimization" and that there "is in general no need to manually adjust the segment shapes to such an extent there is need for a separate optimization of the segment MU." Additionally, the customers were instructed -Do not uncheck the "Segment shapes" check box; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the noted software version numbers; and complete and return the Reply Form via fax to: RaySearch Americas Inc. at 888-501-7195; email: freddie.cardel@raysearchlabs.com and/or email to: Raysearch Laboratories AB at niclas.borglund@raysearchlabs.com. For further information and return of the Reply Form contact For the Americas: Director of Customer Support, RaySearch Americas at +1877 778 3849 or freddie.cardel@raysearchlabs.com; and For Europe, Asia and rest of the world: Director of Service, RaySearch Laboratories AB at +46 8 5450 6130 or niclas.borglund@raysearchlabs.com.
Recall letters were sent to Sales reps and distributors on May 7, 2007. Questions should be directed to William Hennig, QA Manager at 973-299-9300.
Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to return all affected product to Varian Brachy Therapy by using the contact information provided in the letter. Replacement product will be provided free of charge to the customers. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.