Class II — North American Rescue LLC.
| Recalling firm | NORTH AMERICAN RESCUE, LLC. |
|---|---|
| Registered facility | NORTH AMERICAN RESCUE, LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Lack of sterility assurance of the 30-0171 |
| Product | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947 g) Trauma and First Aid Kit; Kit Product Code: 80-0948 h) Trauma and First Aid Kit; Kit Produ… |
| Quantity | 11404 each |
| Distribution | US Nationwide distribution |
| Initiated | 2020-08-21 |
| Classified | 2020-09-25 |
| Terminated | 2024-01-31 |
| Recall number | Z-3018-2020 |
| 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 — North American Rescue LLC. (Z-3018-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86340/
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