U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, blood culturing - Product Code MDB
Causa
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Acción
BD Diagnostics initiated a field correction by phone on December 9, 2013, to affected customers and followed the calls with letters, e-mails, or fax. BD Diagnostics sent a secondary Urgent Field Corrective Action letter dated November 2013 to all affected customers. The recalling firm Secondary notifications were serial number specific and explained that some BD BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities. Specifically, the Anonymous vial indicator lights which should appear yellow may instead appear more green in color.
BD noted that affected instruments continue to function properly and will not report an incorrect result. The issue is limited to the yellow indicator lights only. Red and green indicator lights appear as intended. BD is developing software to correct this issue and anticipates that the new software will be available to begin instrument updates by February, 2014. The new software will not affect instrument if the indicator lights are functioning as intended. Until the software can be updated on your instrument, BD provided workflow instructions to ensure that the indicator light issue does not occur.
For questions regarding this recall call 410-316-4054.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Filler, bone void, calcium compound - Product Code MQV
Causa
Rti surgical, inc. of alachua, fl is recalling their opteform allograft paste, 5cc as it may contain a 10 cc fluid dispenser. the 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
Acción
RTI Surgical issued a: URGENT: Medical Device Recall Notification dated December 6, 2013 to their customer. The customer was instructed to quarantine the product immediately and return to RTI Surgical, Inc. for final disposition. For questions or concerns, call 386-418-8888.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Component, external, limb, ankle/foot - Product Code ISH
Causa
Ossur initiated this recall of the symbionic leg because it may have a possible defect in a small batch of electronics.
Acción
OSSUR contacted all affected customers via phone on February 12, 2013, informing them that a voluntary recall for this product has been implemented, along with the recommended instructions to return the product. A new replacement prosthetic will be provided to the customer.
OSSUR has inspected and made appropriate modification to all inventory. ¿ssur will also further strengthen the design and our manufacturing process to ensure an even more robust product.
For further questions please call (949) 303-3239.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Defective component may cause extension sets to leak.
Acción
Vygon sent an Urgent Medical Device Recall letter dated January 7, 2014 to each customer via courier service and email. The letter identified the affected product, problem and actions to be taken. The recall letter instructs customers to: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately. 2. Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form 3. Fax or email the form to Vygon including customer contact information. 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number. 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. 6. All inventory will be credited or replaced at no cost to the customer. Distributors were provided with instructions on how to handle product that was further distributed by them. For questions contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
Ge healthcare has become aware of a potential safety issue involving the innova systems. the innova system can unexpectedly stop delivering x-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. no injuries have been reported due to this issue.
Acción
GE Healthcare sent an "Urgent Medical Device Correction " letter dated December 10, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the Safety Issue,
The long term solution is to provide a software correction for all of the affected systems that were distributed. The plan for public warning is to contact all customers with an affected system by means of an Urgent Medical Device Correction letter within the US. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to the following titles within the affected accounts:
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 phone numbers: United States: 800 437 1171
For other countries, please contact your local GE Healthcare Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The synthes driving cap/threaded can bind in the im nail radiolucent insertion handles when assembled becoming difficult to separate.
Acción
Synthes sent an Urgent Notice - Medical Device Recall Letter dated January 7 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
Action to be taken: Our records indicate that your facility has the product(s) subject to this Recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock.
Please take the following actions:
If you DO have any of the identified devices, please take the following steps:
"Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization Number.
"Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided.
"Return the Verification Form (page-3 of this letter) with the product to:
"Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
If you DO NOT have the identified product, please take the following steps:
"Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. :Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information.
"Return the documents to DePuy Synthes by:
" Fax: 877-271-1473 or
" Scan/email: FieldAction@synthes.com
If you have any questions,please call 610-719-5450. Thank you for your attention to this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Plate, fixation, bone - Product Code HRS
Causa
The drill template and the saw guide for the ulna osteotomy system may exhibit jamming, bending, or breaking of the screw connecting the saw guide to the drill template or jamming, bending, or breaking of the k-wire during fixation of the drill template.
Acción
A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Photocoagulator and accessories - Product Code HQB
Causa
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Acción
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.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pump, infusion, insulin - Product Code LZG
Causa
Specific lots of insulin cartridges that are used with the t:slim insulin pump may be at risk for leaking. a cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
Acción
Tandem Diabetes Care sent an Urgent Medical Device Voluntary Recall letter dated January 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check the lot numbers of their cartridge supply against the llist of affected lot numbers. Do Not use any cartridges from the lots affected by this recall. If customers don't have useable cartridges, discontinue using the pump and revert to their backup plan until new supplies arrive. Customers were instructed to call Tandem Technical Support at 1-877-801-6901 to receive replacement cartridges at no charge. Customers were asked to return the enclosed return response form via email, fax, or mail. UPDATED: Tandem Diabetes Care expanded the recall om January 20, 2014. Tandem Diabetes Care¿, Inc. (NASDAQ: TNDM), or Tandem, today announced that it is expanding a voluntary recall of specific lots of insulin cartridges that are used with the t:slim¿ Insulin Pump.
For questions regarding this recall calll 858-366-6900, ext 6963.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Photocoagulator and accessories - Product Code HQB
Causa
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Acción
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.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 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 immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
Causa
Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
Acción
The firm, Medtronic, sent an "URGENT-V voluntary Market Removal (Recall)" communication letter and questionnaire packet (via FedEx) dated January 3, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the product from normal storage locations; Do not use the product; and as applicable, contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product or call our Global Quality Department at 800-876-3133 ext 3197. In addition, the customers were instructed to disseminate this information to additional personnel within your facility as appropriate.
A Medtronic Sales Representative will contact you to facilitate the return of any impacted Set Screw Retaining Drivers you may have in your possession.
If you need assistance or if you have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or our Global Quality Department at 800-876-3133 extension 3197.