Recall Z-0764-2017
Teleflex Medical · initiated November 18, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.
Codes / lots: Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.
Reason for recall
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
FDA-determined cause: Packaging process control
Action taken
The firm, Telexflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 11/18/2016 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any affected products; complete and return the Recall Acknowledgement Form by fax to 1-855-419-8507, Attn: Customer Service or email to: recalls@teleflex.com (even if you do not have any affected product) and return the product with the completed Recall Acknowledgement Form. A customer service representative will contact you with a RGA # and provide instructions for the return of the product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Details
- Recall number
- Z-0764-2017
- Initiated
- November 18, 2016
- Terminated
- November 24, 2017
- Product code
- GDT – Staple, Removable (Skin)
- Quantity
- 96,402 units (9,120 ea US, 87,282 ea OUS)
- Distribution
- Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC