FDA Device recall Z-0211-2022
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
- FDA Device
- Class II
- terminated
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class II recall of QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200 by Z Medica, citing lack of Packaging seal integrity may result in a sterile barrier breach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0211-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-22 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Z Medica |
| Distribution | US |
Product
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Reason
Lack of Packaging seal integrity may result in a sterile barrier breach.
Identifiers
| code_info | Lot# 12645 UDI I Primary DI Number: 00841495102004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0211-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.