# FDA recall Z-0938-2021

> **Alung Technologies Inc** · Class II · device recall initiated 2020-12-18.

## Product

ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

## Reason for recall

CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component  to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0938-2021
- **Recalling firm:** Alung Technologies Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-18
- **Report date:** 2021-02-10
- **Termination date:** 2021-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2021

## Citation

> AI Analytics. FDA recall Z-0938-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0938-2021. Source: US FDA. Licensed CC0.

---

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