Recall Z-2520-2021— North American Rescue LLC.
Class II · Terminated
Class II FDA medical device recall by North American Rescue LLC., initiated 2021-08-27, terminated 2024-01-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 10 ga ARS Decompression Needle, Part Number ZZ-0298. Reason: The device includes the incorrect Instructions for Use..
- Recalling firm
- North American Rescue LLC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-27
- Terminated
- 2024-01-19
- Firm location
- Greer, SC, United States
Product description
10 ga ARS Decompression Needle, Part Number ZZ-0298
Reason for recall
The device includes the incorrect Instructions for Use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.