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
Reported: May 24, 2017 Initiated: March 24, 2017 #Z-2108-2017
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.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 3594 eaches
- Distribution
- 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
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teleflex Medical. Units affected: 3594 eaches.
Why was this product recalled? ▼
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2108-2017.
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