# FDA recall Z-0163-2022

> **Smiths Medical ASD Inc.** · Class III · device recall initiated 2021-07-15.

## Product

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

## Reason for recall

Two devices were labeled with the same serial number

## Distribution

UK

## Key facts

- **Recall number:** Z-0163-2022
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-15
- **Report date:** 2021-11-03
- **Termination date:** 2023-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2022

## Citation

> AI Analytics. FDA recall Z-0163-2022. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0163-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*