—#151117

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.

FDA product code: GDT — Staple, Removable (Skin)
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.

Why it was recalled

Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

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.

Timeline

Recall initiated: 2016-11-18
Terminated: 2017-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151117. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.