Z-2108-2017 Class II
FDA device recall Z-2108-2017 was initiated by Teleflex Medical on March 24, 2017 and is designated Class II. Reason for recall: Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device. Affected quantity: 3594 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- March 24, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3594 eaches
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.
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
Code Information
73H1600207