Recall Z-2612-2017 ยท FRO Dressing, Wound, Drug
Z-Medica, LLC
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative,
| Date | May 17, 2017 |
| Status | Terminated |
| Reason | Packaging breach may compromise sterility |
| Root cause | Packaging process control |
| Action | Z- Medica issued recall letters dated May 15, 2017, on May 17 2017, advising users of the problem and requesting customers to check their inventory and return product for replacement. Distributors requested to sub recall. Customers with questions were instructed to contact (203) 774-5686. |
| Quantity | 2910 pieces |
| Distribution | Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123387 | QUIKCLOT HEMOSTATIC DRESSING Z-Medica, LLC, Apr 12, 2013 |