mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure. All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761 Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals/Surgeons 100% of the notifications will be tracked to ensure delivery of the notifications. An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product. Accounts will be deemed unresponsive after 3 attempts.
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated December 11, 2013 to its consignees. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/ Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees were instructed to immediately contact your local GE Healthcare Service Representative if you observe any inappropriate performance or excessive movement of the monitor suspension yoke. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following numbers: United States: 800-437-1171, Japan: 0120-055-919, for other countries contact your local GE Healthcare Service Representative.
Consignees were notified by "Urgent Medical Device Recall" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation at 1-508-683-4678.
A Service Bulletin and a customer notification letter were sent on 4/3/2014 for all the customers who purchased the Shimadzu Digital X-Ray System (Catalog No. DAR-8000f). The notification informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
VIASYS will initiate a field correction for units that have been distributed. The correction consists of testing the units and replacing those that have been found to contain the defect. Method of communication will be by certiified mail to identify consignees and receipt of the communication will be tracked. Letters "Viasys HealthCare Urgent Medical Device Field Correction (Recall)" were sent 7/17/07 to both domestic and international customers.
An Urgent Medical Device Recall letter dated 4/24/17 was sent to customers to inform them that there is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. The letter informs the customers of the issue, impact, action, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at Http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the US and Canada, customers outside the U.S. and Canada are instructed to contact their local Beckman Coulter representative.
Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.
Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.
Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.
A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions: 1. Stop using and remove from your inventory the affected product. 2.Complete and return the included Facsimile Form as AMO. If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
On March 3, 2004, shipping personnel noted that IntraStent product S15-36, lot 494428, was labeled as IntraStent product S15-26. Six units from the lot were in distribution. On December 29, 2005, customers were sent a Field Action Form to record the number of used or available for return stents at their facility. The form instructs the customer to return the completed original form and any unused stents.
Medtronic sent a Medical Device Correction letter dated February 2014 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: If you have patients with cycling enabled or wish to use cycling, use the updated calculations and graphs available online at professional.medtronic.com/cycling to assess the impact of cycling on device longevity. Medtronic will update the product labeling in the second half of 2014. " Remind your patients to continue to check their battery status. Instructions on how to check battery status can be found in the patient programmer or recharger system manual. " Pain Stimulation Trialing Only: The cycling feature should not be enabled on the External Neurostimulator (ENS) when estimating device longevity because the resulting longevity estimate for non-rechargeable devices may not provide accurate information. Consignees were also instructed to acknowledge receipt of the notice by completing the attached reply form and returning it to Medtronic using the contact details on the reply form. For questions consignees can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7am - 6pm CST. For questions regarding this recall call 800-707-0933.
The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
A letter, "Urgent Device Correction" dated July 8, 2008 was sent via certified mail to implanting surgeons advising them of the issues and guidance on how to mitigate the problem. A communication was also sent to all sales representatives and territory offices on July 15, 2008. For questions, please contact Depuy Orthopaedics, Inc. Customer Service at 1-800-473-3789.
Invacare sent an "URGENT: RECALL INFORMATION" letter dated August 31, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of any affected product and to call the Recall Support Line at 877-496-5041 for assistance.
Integra sent an Urgent Product Recall Notification letter dated October 14, 2011 to all affected customers via US Mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, discontinue use, quarantine and return any available affected lot numbers. Customers were instructed to distribute this communication to any customers to whom they have shipped the affected product. Customers were advise to complete the enclosed Recall Acknowledgement and Return Form and return it as soon as possible to Integra Customer Service. For questions contact Integra Customer Service at 609-936-2659.
Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.
Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions. Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398.
EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 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 segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226. For questions regarding this recall call 425-307-9200.
Boston Scientific sent an URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED letter dated November 21, 2011. The letter described the product and the problem. Customers were instructed to segregate the affected product immediately and return it to Boston Scientific. Distributors were advised that the recall removal depth is to the hospital level and the recall removal notification should be forwarded to their customers. For questions regarding this recall call 763-494-1133.
An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall Notification Letter are instructions: "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 induding a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."
On 6/18/13, an "Urgent Kit Recall" notification letter was mailed to all customers informing them of the recall and instructing the consignee to remove and return any affected product lot numbers to Bard Access Systems through return goods authorization. Customers may contact 800-290-1689 if questions.
The firm, Anspach sent an "URGENT" Medical Devics Removal" letter dated April 24, 2013, to its customers. Customer Immediate Actions: 1. Screen your current inventory and return all Anspach Pneumatic Drill System without a pressure Relief valve (PRV) from your inventory. 2. If you have any product listed on the attached form to arrange for immediate return and replacements. 3. complete the attached Customer Reply form indicating the product being returned. 4. Upon receipt of a replacement product, equipment being returned must be received by Anspach within 10 business days of the replacement request. Should you have any queries, please contact Anspach Product Support at (800) 327-6887.
Stryker Neurovascular sent an Urgent Field Safety Notice on June 28, 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 immediately check their internal inventory and quarantine all subject devices pending return to Stryker. Circulate the Field Safety Notice internally to all interested/affected parties. Maintain awareness of this notice internally until all requred actions have been completed within their facility. Inform Stryker if any of the subject devices were distributed to other organization. Complete the attached customer response form and return to their Stryker Representataive. For questions regarding this recall call 510-413-2500.
The firm sent URGENT PRODUCT RECALL notices dated 4/15/2011 to Risk Managers/Recall Administration (Chief of Vascular Surgery and or Interventional Radiology). The letters explained the problem with the devices and the action to be taken. Consignees were instructed to return the recalled devices to Cook Medical for credit or replacement. Customers with questions or concerns can contact the firm at 800-457-2235.
INITIAL RECALL Urgent medical Device Safety Information & Corrective Action letter dated 07/18/05 was issued to physicians listing clinical Implications and patient management recommendations. EXPANDED RECALL Press was issued January 23, 2006. Urgent Medical Device Safety Information & Corrective Action letter, dated 01/21/06, was issued to physicians listing a summary of previous communication to physicians, advisory population update, and information relative to a second population of devices manufactured between October 19, 1998 and December 5, 2000. This letter gives the observed rate of occurrence, clinical implications, projected rate of occurrence and recommendations.
The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.
On February 2, 2018, the firm issued an Urgent Medical Device Correction notification to their distributors to make them aware of the device correction. The firm requested that distributors further disseminate an attached recall letter to consignees. The communication addressed to consignees advised of the issue affecting the device. Consignees were asked to inform users that the device is for armboard use only, and not to be used with the product system's leg support. The notice informed consignees that the firm would provide new units upon completion of development along with revised Instructions for Use. Customers with questions concerning this Urgent Medical Device Correction were referred to Allen Medical Customer Service: (800) 433-5774, 8:30AM-5PM (EST)
International Technidyne Corp. sent a letter dated March 23, 2011, 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 their inventory to determine if they have any of the affected product. If they have any of the affected product, customers were instructed to stop using it and remove it from their inventory. Customers were also instructed to complete the attached Customer Account Tracking Form and return it by fax to (732-635-0144) or e-mail (techsupport@itcmed.com) or mail to: ITC Technical Support 20 Corporate Place South Piscataway, New Jersey 08854 For any questions call the Distributor or ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International), ext 4707.
The firm, Stryker Medical, sent an "Urgent Medical Device Correction" letter dated February 26, 2010, to all customers. The letter describes the product, problem and action to be taken by customers. The letter states that Stryker field service tech will contact the firm and perform device corrections within four months. The customers were instructed to locate the recalled stretchers and verify that there is no grinding noise when activating the fowler. If the fowler exhibited a grinding noise, the customers were instructed to remove the stretcher from service and contact the recalling firm at 800-STRYKER, option 3. Note: Do not put the stretcher back into service until it is repaired by our field service representative. The customers were also instructed to return the enclosed post card to confirm receipt of this notice; inform any new users and advise the firm of new locations if any of the listed stretchers were on loan or sold, and advise the firm of the obsolescence by providing the serial numbers if any of the listed stretchers were disposed of. If you have any urgent questions or concerns, contact (269) 324-6884. Normal hours are Monday-Friday 8am-5pm(EST).
Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.
Alpine Biomed ApS sent a Recall Notification/ Field Safety Notice dated April 8, 2013 to all affected customers via e-mail and courier. Alpine Biomed ApS advised their customers to upgrade all installations of Keypoint.NET v2.20 to Keypoint.NET v2.21. Alpine BioMed ApS has recommended that their customers complete and return the verification form to QA/RA Engineer Michael Jacobsen at e-mail michael.jakobsen@natus.com. These actions and the return of the verification form to Alpine Biomed ApS should be completed within 3 months of receipt of the recall notifications. If any assistance is required to complete these actions, please contact Technical Support Engineer Michael Jensen via e-mail michael.jensen@natus.com, alternatively QA/RA Engineer Michael Jacobsen by e-mail michael.jakobsen@natus.com.
Argon Medical sent an Urgent Product Recall letter to consignees on 11/15/2007. They requested that users immediately quarantine and return any product remaining at their facility, utilizing instruction on response card. Distributors were directed to issue the recall to their customers and return all retrieved product to Argon.
Hospira sent Urgent Device Recall letters dated February 14, 2011 to their customers on the same date, informing them that Hospira had received complaints of the Plum XL, XLM and XLD infusion pumps in which the audible alarm failed. If the audible alarm fails and the user does not notice the visual alert, the user may not be aware of the change in pump status such as air-in-line or occlusion. This may result in a delay or interruption of therapy which may result in serious injury and/or death. Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. They were also instructed to ensure that all personnel in their facility are following Hospira's Technical Service Manual for routine decontamination of the pumps and cleaning of the buzzers during preventative maintenance, including inspection of the buzzers for leg lifting. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached reply form and return it to Hospira via fax at 1-866-382-4228.
Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.
Baxter sent recall letters dated 11/14/05 to all of their 6060 pump customers on the same date via DHL overnight delivery. The accounts were informed of the reports of failures within the PCA profile and interruptions of therapy in various profiles. Due to the obsolescence of certain critical components, Baxter is conducting a controlled removal of all 6060 pumps from the market. Baxter will coordinate with customers individually to ensure a smooth transition to a substitute device. Baxter provided interim instructions to discontinue use of the PCA profile to avoid over infusion or non-delivery conditions, and to discontinue the use of the pump for therapies where interruption of the infusion could cause immediate patient harm. Baxter representatives telephoned each account within 48 hours of the letter, and visited them within a week to help the customers transition to other infusion pumps. A press release issued on 11/15/05. Baxter sent a follow-up recall letter to the accounts on 6/20/06, informing them that service repairs for the 6060 Infusion Pump will cease after 12/31/06, and compensation requests cannot be processed for pumps received after 12/31/06. Production of sets for the 6060 will cease on 10/1/06, and will not be available after 12/31/06. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the current inventory of 6060 pumps remaining at the facility.
All affected customers are being sent an 'Important Radiation Safety Notification' letter dated November 10, 2005, that identifies affected units, the associated potential hazards, and the planned modification. A Copy of the Technical Reference Manual will be included with the customer letter.
Mindray issued an "Urgent: V Series Monitoring System Corrective Action" letter dated 9/24/2012 via certified mail with return receipt verification to all hospitals. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 to arrange for relplacement of the affected product. For questions regarding this recall call 201-995-8407.