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 | The device includes the incorrect Instructions for Use. |
| Product | 10 ga ARS Decompression Needle, Part Number ZZ-0298 |
| Quantity | 51,424 units |
| Distribution | Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland |
| Initiated | 2021-08-27 |
| Classified | 2021-09-23 |
| Terminated | 2024-01-19 |
| Recall number | Z-2520-2021 |
| 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-2520-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88603/
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