FDA Device recall Z-2520-2021
10 ga ARS Decompression Needle, Part Number ZZ-0298
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of 10 ga ARS Decompression Needle, Part Number ZZ-0298 by North American Rescue, citing the device includes the incorrect Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2520-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-27 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | North American Rescue |
| Distribution | PR |
Product
10 ga ARS Decompression Needle, Part Number ZZ-0298
Reason
The device includes the incorrect Instructions for Use.
Identifiers
| code_info | Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All North American Rescue recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2520-2021%22
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