Recall Z-0764-2017— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2016-11-18, terminated 2017-11-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-18
- Terminated
- 2017-11-24
- Firm location
- Research Triangle Park, NC, United States
Product description
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.
Reason for recall
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Data sourced from openFDA. This site is unofficial and independent of the FDA.