Recall Z-2108-2017— Teleflex Medical
Class II · Completed
Class II FDA medical device recall by Teleflex Medical, initiated 2017-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Completed
- Initiated
- 2017-03-24
- Firm location
- Research Triangle Park, NC, United States
Product description
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
Reason for recall
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.