Recall Z-0764-2017 ยท GDT Staple, Removable (Skin)
Teleflex Medical
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.
| Date | Nov 18, 2016 |
| Status | Terminated |
| Reason | Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. |
| Root cause | Packaging process control |
| Action | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.