Recall Z-2108-2017 ยท GDT Staple, Removable (Skin)
Teleflex Medical
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
| Date | Mar 24, 2017 |
| Status | Completed |
| Reason | Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.