Device product
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
Z-2108-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 77102
- Status
- Completed
- Classification
- Class II
- Quantity
- 3594 eaches
- Official record key
device-enforcement:Z-2108-2017
Official wording
Reason: Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Code information: 73H1600207
Distribution pattern: Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France
Derived failure modes
-
Unknown
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.