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.
FDA Recall Z-0764-2017 · Posted None
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeGDT
Date Initiated2016-11-18
Date Terminated2017-11-24
Product Quantity96,402 units (9,120 ea US, 87,282 ea OUS)
Reason for Recall
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Firm 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: [email protected] (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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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