Recall Z-0211-2022 ยท FRO Dressing, Wound, Drug
Z-Medica, LLC
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
| Date | Sep 22, 2021 |
| Status | Terminated |
| Reason | Lack of Packaging seal integrity may result in a sterile barrier breach. |
| Root cause | Under Investigation by firm |
| Action | Z-Medica notifed the customer via email on Wednesday 9/22/2021 and requested to place the products on hold. A formal notification letter was sent to the customer on 9/23/2021. Letter states reason for recall, health risk and action to take: We are requesting that you return all units of lot 12645 to Z-Medica, LLC ( 4 Fairfield Boulevard, Wallingford, CT 06492, ATTN: Recall - Regulatory Affairs). Please and return the attached Acknowledgement Form via email to joseph.azary@teleflex.com. If you have distributed any units of this lot number, please contact your customers and arrange for return of |
| Quantity | 2400 units |
| Distribution | US Nationwide distribution in the state of NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072474 | QUIKCLOT EX Z-Medica Corporation, Oct 16, 2007 |