—#154971

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

FDA product code: GDT — Staple, Removable (Skin)
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 73H1600207

Why it was recalled

Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

Root cause (FDA determination)

Error in labeling

Action the firm took

Teleflex sent an Urgent Medical Device Correction Notice dated March 24, 2017, to consignees. The letter requested that they check inventory on hand and quarantine product for return. They letter also requested that distributors conduct a sub-recall. The letter included a reply form to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

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

Timeline

Recall initiated: 2017-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.