QuikClot Combat Gauze-For Temporary External Use To Control Traumatic… — Class II medical device recall Z-0211-2022
Terminated recall by Z-Medica, LLC, reported 2021-11-17, distributed nationwide. Lack of Packaging seal integrity may result in a sterile barrier breach.
| Recall number | Z-0211-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Z-Medica, LLC, Wallingford, CT, United States |
| Recall initiated | 2021-09-22 |
| Classified | 2021-11-05 |
| Reported by FDA | 2021-11-17 |
| Terminated | 2024-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 2,400 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00841495102004 |
| Lot numbers | 12645 |
| Model numbers | 200 |
Product
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Reason for recall
Lack of Packaging seal integrity may result in a sterile barrier breach.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0211-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.