Class II — Z-Medica, LLC
| Recalling firm | Z-MEDICA, LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Lack of Packaging seal integrity may result in a sterile barrier breach. |
| Product | QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200 |
| Quantity | 2400 units |
| Distribution | US Nationwide distribution in the state of NC. |
| Initiated | 2021-09-22 |
| Classified | 2021-11-05 |
| Terminated | 2024-06-11 |
| Recall number | Z-0211-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Z-Medica, LLC (Z-0211-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88818/
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