mfarrington/biobert-ner-fda-recalls-dataset huggingface dataset:
The firm, King Systems, sent an "URGENT PRODUCT RECALL" letter dated January 14, 2011 to its customers. King Systems sent a follow-up "URGENT PRODUCT RECALL" letter dated March 3, 2011 which "SUPERSEDES" the January 14, 2011 recall letter with attached instructions to its customers. The letters described the product, problem and actions to be taken by the customers. The customers were instructed to notify all their purchasers of this recall; immediately cease sales and use of the affected products; identify all inventory on hand or returned to them by their customers; REMOVE Triad Group lubricant from King LT-D and LTS-D kits according to King instructions; quarantine the Triad lubricant, re-seal the LT-D and LTS-D kits and destroy Triad lubricant or return to Triad according to King instructions, and complete, sign and return Recall Acknowledgement Form via fax to: 317-776-6827 or email to: triadluberecall@kingsystems.com. King Systems will provide replacement lubricant packs to all customers. Customers with questions regarding product return, replacement, hospital notification or concerning the information requested above, please contact Customer Service at 1-800-642-5464. If you have any regulatory questions about the recall, please contact Director of Quality Assurance and Regulatory Affairs at 1-800-642-5464.
A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
The IV administration sets were recalled by letters dated 6/9/03, advising the accounts of the discoloration of the sight chamber and adapters due to the use of non-radiation grade plastic resin in the manufacture of these components of the sets and requesting the return of the sets for credit. These letters were accompanied by a customer ship history/business reply form, which listed the specific set list numbers and lot numbers shipped to the direct account. The direct accounts were requested to send copies of the enclosed recall letter with the listing of all affected sets to their subaccounts. Abbott sent recall letters dated 6/13/03 to those accounts who received I.V. set list 018810458, lot 910824W packed in cases with Liposyn II 20% Kits, list 97920403, lot 92552DF and list 97930403, lot 94553DF. These accounts were informed of the problem with the administration sets and were requested to remove the sets from the Liposyn II cases and return the sets for credit. Abbott sent recall letters dated 7/7/03 to distributors and veterinary clinics receiving the 12 additional lots of primary I.V. sets, list numbers 018810448 and 089620448, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 7/7/03 to the third party manufacturers receiving the affected drip chamber components, informing them of the problem with the drip chambers and requesting the return of the affected lots. Abbott sent recall letters dated 8/19/03 to hospitals and distributors receiving the 9 additional lots of I.V. sets, list numbers 119440402, 119480402, 120300412, 122590402 and 123120401, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 5/13/04 to hospitals and distributor
The recalling firm notified end users by letter on 05/01/06 and advised users of possible communication error between afterloader devices and software. The notification also advised that the control program for the devices has the potential to lead to a misadministration of treatment in cases where data is manually entered by the user. The firm additionally advised that user may continue to use the afterloader devices if following the listed cautionary statements. A software upgrade is planned to be implemented at the user site''s next regularly scheduled radiation source exchange. A response form is enclosed with the notification and users are requested to return the customer receipt verification via fax.
On 1/19/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.
AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated February 2, 2012 to the single customer. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs the customer to identify and segregate the affected product. A Morpheus Smart PICC Recall Reply Form was enclosed for the customer to complete and return via fax to 518-798-1360. Contact AngioDynamics Customer Service at 1-800-772-6446 for questions regarding this notice.
Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
A Preliminary Customer Information Letter (dated 7/4/14) was emailed to customers on 7/05/14 from Mitsubishi's sales and service representative in Germany. The letter informed customers of the potential safety issue associated with the VERO Linear Accelerator and the recommended actions to be taken. A formal URGENT FIELD SAFETY NOTICE Letter (dated 7/15/14) was emailed to customers on 8/07/14 from Mitsubishi's sales and service representative in Germany. The letter instructed customers to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions to be taken.
Integrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.
Siemens sent an Urgent Field Safety Notice letter on January 16, 2016, to all affected customers The letter identified the product, problem, potential risk, and actions to be taken. Customers were instructed to immediately pass this information to all those who need to be aware and instruct personnel accordingly. Siemens ask that if the device/equipment is no longer in the customers possession to forward this safety notice to the new owner of the device/equipment.
Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.
XVIVO Perfusion, part of the Vitrolife Group, sent out a "Partial recall of Perfadex with THAM" letter on May 13, 2011 to all affected customers. Customers were instructed to to quarantine all Perfadex with THAM. Replacement THAM was to be shipped by Vitrilife within a few days and the exchanged THAM was to immediately sent to Vitrolife, Englewood, CO. For additional Information please call (303) 762-1933
Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Phase 1 - Important Notice and Technical Note #200 058 - "Accuracy problems in Leksell GammaPlan 8.0 image fusion", dated December 10.2007 and Field Change Order #200 058, "Technical Note: Accuracy problems in Leksell Gamma Plan 8.0 image fusion", dated January 7, 2008 were sent to affected customers and all field service engineers as notification of the problem. The notice describes the product, problem and actions to be taken by customers. The firm recommended that the customers not use the fusion function until their Leksell GammaPlan(R) is upgraded to version 8.2. For further question, do not hesitate to contact your Elekta support respresentative at
Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.
An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to: -Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the patient has any of the medical conditions described. -Verify that the patient has hematocrit within the range of 30% to 55%. If not, immediately transition the patient to an alternate INR monitoring method. -Perform INR verification testing for the patients using a laboratory INR test method. Immediately transition any patient with a significantly discrepant low result on the INRatio¿¿ PT/INR Monitor system to an alternative INR monitoring method. -If have forwarded product to another customer, please provide a copy of this letter to them. -Please complete and FAX or e-mail the enclosed Reply Form (Appendix B the last page of this notice) within 10 days to confirm your receipt of this notice. Customers can contact Alere INRatio Recall Hotline by phone at 1-877-929-2579, for questions regarding this notification. Additionally, a website has been established providing information and frequently asked questions. www.inr-care.com Please FAX or e-mail the completed Reply Form to: Alere San Diego, Inc. Fax: 1-877-929-2580 E-mail: Alere4319@stericycle.com.
Customers were sent a product Safety & Recall notification via email or regular mail begining 12/03/04 through 12/08/04. A Product Recall form requested the customer for feedback as to Quantity Used, Quantity to be Retained and Quantity to be returned . The Customer Recall Notication states that if no Administration Sets from alternative lots are available and the use of the volumetric pump is essential, follow the instructions in the attached Customer Information Bulletin, which describes how to identify a set which does not have the defect. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths.
Integra LifeSciences Corporation sent an URGENT Product Recall Notification letter dated September 29, 2010, to all affected customers. Integra NeruoSpecialists were informed of the recall via telephone conference call and recall notification letters sent by e-mail. Letters were also sent to customers by Federal Express with copies of e-mail provided to Interga Neuro Specialists on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine any affected product and contact Integra Customer Service at 1-800-654-2873, select option 5, followed by option 3. Customers were instructed to fill out and return the enclosed "Recall Acknowledgement and Return Form" indicating whether or not they possessed any of the affected product. For any questions related to this recall call 1-800-654-2873 and selection option 1.
Consignees were contacted by an URGENT: Product Safety Information Voluntary Recall Notification letter dated March 11, 2008 with attached Safety Action Bulletin 08-SAB01 dated February 27, 2008 and email between March 7 and March 13, 2008. The consignees will need to return the device to be evaluated in the Smiths Medical PM, Inc.
Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.
Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.
Letter was sent to all customers requesting return of the unused lot on 11/20/2003.
The manufacturer notified consignees by phone, via fax with a letter, and e-mail on 07/20/11. The letter asked customers to check their inventory for any of the affected product, and if they had any product remaining to place the amount in the list "Returned." If there was no product left, then the amount used should be placed in the list "Used." Customers needed to complete and sign the document, being sure to send it and any remaining product to the address provided. Credit would be issued once goods were received. If customers have questions, they should contact the firm.
The firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.
A Product Recall Notice was sent on February 27, 2004 to consignees instructing them to discontinue use of the recalled product and return products to 3M.
The recalling firm initiated the recall via email on 2/25/2022 with the Urgent Field Safety Notice dated 2/7/2022 attached. The email says to ensure the safe and effective use of the device, the consignee is to reply (1) they have received the Field Safety Notice; (2) the affected device is installed at the hospital and the the addressee of the email is the correct recipient for the communication; and (3) users at the hospital have been made aware of the content and adhere to the User Corrective Action described in the enclosed notification. The email asks the consignee to answer each of the 3 points to ensure the effectiveness of the communication. The notice explained the issue and provided details of specific conditions that are required for the error to occur, the affected workflows, and the magnitude of the potential error. User Corrective Action is provided giving instructions to prevent the issue from occurring. The action provided was: When using the ETD CBCT module, always ensure that during the CBCT X-ray Reference Acquisition step (CBCT offset detection), a treatment beam and not a setup beam is loaded on the Varian treatment console. If a setup beam is loaded, the word Setup will display in the ETD software, and it is not safe to continue. (A figure is provided to show the display. It shows a screen where a setup beam is active and it is not safe to continue and also shows the display of a treatment beam that is active and it is safe to continue.) In this case, the user is to assure they first switch to a treatment beam on the Varian treatment console and confirm the change in the Brainlab ETD software before continuing. Brainlab will provide a software revision of ExacTrac Dynamic with the described issue corrected to all affected customers. Brainlab will actively contact the consignee to schedule the update, starting in May 2022. Appropriate personnel working in the consignee's department are to be made aware of the notification.
The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated August 2, 2010, via Federal Express to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory to identify the affected product; retrieve all affected product and return it their branch or agency warehouse for reconciliation; reconcile all product(s) on the attached Product Recall Acknowledgement Form and fax to (201) 831-6069, and return the affected product via Inter-Org Transfer and ship to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.
GE issued an Urgent Medical Device Correction letter dated September 19, 2013, to all affected customers via Fed Ex overnight mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected product, isolate all affected product and return the attached form via fax to 800-535-7923. Once the information is received, customers would be contacted with an RMA and replacement information. If product was distributed further the notice should be forwarded to those customers. For questions customers should call 1-800-345-2700, option 2 followed by ooption 2. For foreign customers 1-800-932-0760, option 2. For questions regarding this recall call 262-513-4122. GE issued a press release on 12/30/2013.
Hologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected A Dealer notification dated 5/13/14 sent by certified mail or Federal Express to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) by letter dated 5/14/14. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.
DeRoyal sent a Recall letter dated July 1, 2010 to all their consignees via UPS Air. The letter identified the product, the problem, and action to be taken by the consignees. Consignees were to complete the Recall Response Form by checking their inventory for DeRoyal Suction Canisters V71-3001, Lot #22622679. Indicate the number of replacement products needed on the Recall Response Form, including the address, reference PO#, etc. to be used for the replacement products and fax the form to DeRoyal at 865-362-3755 no later than July 7, 2010. Recalled products were to be returned to DeRoyal via UPS Ground Attn: Quality Control 300 DeBusk Lane Powell, TN 37849 Once the recalled product was received by DeRoyal, the replacement product would be shipped per the instructions on the Recall Response Form. Distributors were to forward the recall notice to their end-users, or provide customer listing so that DeRoyal may contact them. For any questions or assistance regarding this recall call 865-362-1037.
The firm, TERUMO Cardiovascular Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 11, 2010, to the consignees. The letter describes the product, reason for correction, what to do in the event of failure, potential hazard, correction, affected population and action to be taken by the customers. The customers are instructed to review the correction notice, assure that all users are aware of this notice, and complete, sign and fax the attached Customer Response Form to Terumo CVS Customer Service at 800-292-6551. The Terumo CVS Customer Service Dept. will contact you upon receipt of the Customer Response Form to schedule the replacement. The firm plans to inspect and correct all units in the field within 5 months. We encourage you to contact Terumo CVS Customer Service at 1-800-521-2818, Monday-Friday, 8 AM-6 PM EST, with any questions or concerns.
Biomet Microfixation (formerly W. Lorenz) sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter to the consignees/customers on October 7, 2010. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to fill out the attached Inventory Reconciliation sheet and fax to 904-741-9425 and if the consignees/customers further distributed this product, they should notify their customers and provide them with a copy of this safety alert (the letter must be given to the personnel responsible for receiving field action notices). If you have any questions, please contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
Zimmer sent an Urgent Medical Device Correction notification letter dated April 24, 2012, with an attached Technical Bulletin listing precautions present in the new Informaiton for Use sent to distributors and customers via E-mail and FED EX. Notifications identified the issue and risks found with the device listing responsibilties, precautions, and procedural precautions. Notifications contained directions to forward information to any sub accounts and clinicians. Zimmer had telephone follow-up with each distributor and customer to assure information was received and is understood. Questions should be directed to Technical Service (800)8511-7019 orCustomer Service(760) 929-1300 or Regulatory Affairs at 1-800-854-7019 . For questions regarding this recall call 574-372-4807.