# FDA recall Z-2520-2021

> **North American Rescue LLC.** · Class II · device recall initiated 2021-08-27.

## Product

10 ga ARS Decompression Needle, Part Number ZZ-0298

## Reason for recall

The device includes the incorrect Instructions for Use.

## Distribution

Distribution throughout US and Puerto Rico  OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland

## Key facts

- **Recall number:** Z-2520-2021
- **Recalling firm:** North American Rescue LLC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-27
- **Report date:** 2021-09-29
- **Termination date:** 2024-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greer, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2021

## Citation

> AI Analytics. FDA recall Z-2520-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2520-2021. Source: US FDA. Licensed CC0.

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