mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
Siemens initiated the recall on 07/22/2008 by forwarding A Customer Bulletin by fax or mail to all affected Siemens Healthcare Diagnostic Branches for communication with the affected customers. The Customer Bulletin informed their customers that the firm is conducting a field correction and requested that they discontinue using any IMMULITE/IMMULITE 1000 kit lot prior to LKPG 1,5 330. They were also instructed to complete attached Completion Notification Form and return to their local Siemens Healthcare office or distributor as soon as possible. The were informed that replacement kits will be provided once the completed forms have been received. The Customer Bulletin recommend their customer discuss the content of the letter with their laboratory director regarding the need to review previous test results, conduct patient follow up, and/or repeat testing. The bias should not impact the in-vitro fertilization clinical application because the average change for samples within the range of 1-3 ng/mL is less than 5%. Although there is a greater degree of shift at higher concentrations, the clinical impact is considered to be relatively low when using the test for the diagnosis of ectopic pregnancy and luteal phase defects because in these situations, the progesterone result should always be considered in conjunction with other tests. PROGESTERONE DETERMINATIONS USED IN THE DIAGNOSIS OF PLACENTAL INSUFFICIENCIES OR FOR MONITORING PROGESTERONE THERAPY MAY HAVE BEEN AFFECTED BY THE HIGH BIAS. The letter also indicated SIEMENS IS INTRODUCING A RE-CALIBRATED IMMULITE PROGESTERONE KIT BEGINNING WITH KIT LOT LKPG1, 5 300, WHICH WILL BEGIN ROUTINELY SHIPPING AUGUST 15 TH. AT THAT TIME, KITS WITH THE PREVIOUS CALIBRATION WILL ONLY BE AVAILABLE UPON REQUEST AND AVAILABILITY OF INVENTORY FOR CUSTOMERS WHO STILL NEED TO PERFORM BASELINING STUDIES. An Important Notice, which is reproduced at the end of this notice below, will be included with the recalibrated kits
An "URGENT MEDICAL DEVICE WITHDRAWAL" notice dated January 26, 2010, was sent to customers via certified mail. The notice described the product, problem and action to be taken by the customers. The customers were instructed: DO NOT USE THESE AFFECTED PRODUCTS. PLEASE RETURN ALL AFFECTED PRODUCTS IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED. The customers were also instructed to report any adverse reactions experienced with the use of the product and/or quality problems to MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078 by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch. The customers were also instructed to check the lot numbers of products in inventory to determine if they have products affected by this withdrawal and complete and return the enclosed Customer Response Form by fax or email. Direct all inquiries to: EXEL International Customer Service 727-827-1922 ext. 0 Monday through Friday 9am-5pm EST or E-mail info@exelint.com
Baxter mailed Urgent Device Correction letters dated 2/10/05 to the domestic accounts on 2/10/05 via first class mail, to the attention of the Director of Nursing, advising them of the following hardware problems and software anomalies and providing workarounds for each. There are potential failures of the pump due to upstream occlusion alarms, electro-static discharge, Key-Only security mode (previously covered by letter dated 4/10/02), system error 32 or 33 codes, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. The accounts were advised that as soon as revised software and hardware is available, Baxter would modify the pumps at no additional charge to the consignee. Any questions were directed to their Baxter Medication Delivery Product Information Center at 1-800-933-0303.
A recall notification letter, dated March 2014, was sent to wholesale distributors and end users.
Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.
Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.
Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.
Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA. "THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY." Questions should be directed to an AMO Customer Service Representative at 1-877-AMO-4LIFE (1-877-266-4543).
Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.
Recall notification was sent via email to Wilson-Cook, sales representatives on 10/08/2003 for personal delivery to the affected accounts. Consignees were advised to quarantine and return all affected product via Federal Express (using Wilson-Cook Medical account) to the recalling firm. A verification form was included at the bottom portion of the notice to be returned with the affected product or faxed to Wilson-Cook. Replacement product or account credit will be provided upon receipt of any affected devices.
AdvanDX sent an e-mail notification along with a PDF file to all customers on October 8, 2010, followed by written notification dated October 6, 2010. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to replace the package insert(s) included with any kits in their inventory with the enclosed package insert(s). Customers were also instructed to fill out the enclosed Acknowledgement of Receipt Form and return it to AdvanDx to confirm that they received the new package insert. For questions regarding this recall contact AdvanDx Technical Support at 1-888-376-0009.
The firm sent a 'A Medical Device Correction Notice' with an attached Acknowledgement and Return Form to all consignees on 1/6/2012 via FedEx and E-mail. The Correction Notice informs customers of the firm's receipt of several complaints regarding the Endoscopic Gastrocnemius Release (EGR) System and the problem with non-retraction of the blade back into the device during surgery. Although no adverse health consequences or patient injuries have been reported to date, the notice is being issued by the firm in order to reinforce the importance of following the additional clarification to the Surgical Technique Manual. According to the firm, this action should serve to reduce the possibility in which the blade may fail to retract into the device. Questions were directed to (609) 936-6832.
Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Osteotech sent out recall letters/questionairres dated April 20, 2012, to Risk Managers/service representatives. The recall was expanded on August 1 2012. The letter identified the product, the problem, and the action to be taken by the customer. Sales Representatives would facillitate the return of any affected product they may have or provide cautionary labels for any affected product and/or support in the completion of the attached questionnaire. Customers were asked to disseminate this information to additional personnel within their facility as appropriate and return the questionnaire to Medtronic.. Customers with questions should contact their Medtronic Sales Representative at 800-876-3133, extension 3197. For questions regarding this recall call 732-542-2800. Osteotech sent an additional letter stating that The OPTIUMTM (DBM) product line was added in error.
Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
Specialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.
GE Healthcare sent an Urgent Medical Device Correction letter dated March 20, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. GE Healthcare will inspect and, if required, correct all affected products at no cost to you to ensure that all design redundancies are in place. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
A Medical Device Correction notification letter dated 8/3/23 was sent to customers. Action to be taken: " Review Quality Control data generated using the affected lot. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns please contact Randox Technical Services.
Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.
The firm began visiting accounts to install new software on 1/17/06 and expects completion of installation at all accounts by 3/31/06.
End-user facilities were contacted by Sunrise Medical Customer Service Team via telephone. All beds were inspected and corrected by factory-trained representatives or by affected locations'' facility engineers.
Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed.
Medical Device Recall Letters were sent on October 3, 2008 to all customers by certified mail. The letters were entitled "URGENT *** MEDICAL DEVICE RECALL (U.S. ONLY). Questions are to be directed to Enterix at 1-800-531-3681,
Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.
GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. A GE Healthcare Service Representative will update the software on the system to address the issue. Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.
The recalling firm notified distributors by letter on 11/23/05 and advised that identified lots of the devices contain a component contaminated with the bacteria Ralstonia picketti. Distributors were instructed to discontinue distribution and discard. Distributors were requested to provide consignee lists to the recalling firm for direct notification to consignees. Distributors were notified that the recalled products have been discontinued. Customers are asked to discard Liquid Activating Reagent Packets and return the response form enclosed for replacement of the packets or alternatively use existing packets by adding user supplied de-ionized or sterile water into the reagent channel of the pouch.
Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form. Further information is available at 800-424-3278.
Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product. Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.
On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.
Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to corporatequality.postmarket@zimmerbiomet.com. Questions or concerns can be directed to Customer Service at 1-866-774-6368
The recalling firm contacted all fifteen (15) of its distributor/customers (not just the distributors that received the affected devices) via telephone on 4/3-5/2006 in order to inform them that the User Instructions had not been included with the needle containment devices that were shipped between 7/5/2005 and 4/3/2006. The firm asked that the distributors check their inventories and if it was determined that User Instructions were missing, report the amount needed to the recalling firm which would in turn send them out. The firm followed up on their recall action via telephone on 7/11/2006, at which time, it was determined that that all of the distributors either had old User Instructions in stock for distribution, or that there were no affected device units left in inventory.
Alliant Healthcare sent an URGENT: MEDICAL DEVICE RECALL letter on 7/21/2011 and 7/25/2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review the recall notification and quarantine any affected product. If product was further distributed, customers were to forward the letter with the Recall Return Response Form immediately to all affected locations and indicate which locations on the Recall Return Response Form. Customers were also instructed to discontinue use immediately, dispose of the affected product per their normal disposal protocol, and fax the Recall Return Response Form to Alliant Healthcare Products at 269-629-5770. Upon receipt of the Recall Return Response Form, a substitute vent valve (non-adjustable only) will be sent to their location for each affected product for which disposal has been properly documented in writing. For questions call 269-629-0300, ext 226.
Customer recall notifications included: a) Telephone notification to highest volume users b) Recall letters were sent via certified mail to all customers June 1, 2006. Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.
AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product. Complete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax the form to 518-798-1360. If customers distributed the affected product, they should inform their customers of this recall action immediately and have them return the recalled units to them. For any questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.
Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
An "Urgent Product Recall" letter dated August 2009 was sent to the customers. The letter described the affected product, problem and the action to be taken by customers. The customers were advised to discontinue use of the centrifuge for repair or replacement with refurbished unit , provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so that BD may inform them of the issue,and return the enclosed response form. For further assistance regarding product replacement and returns contact our Technical Services Department at 1-800-638-8663.