# FDA recall Z-2321-2024

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2024-05-30.

## Product

Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara.  Intermittent positive pressure breathing device.

## Reason for recall

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter.  The handset plug is required to ensure proper operation and ventilator gas flow.

## Distribution

Nationwide distribution. International distribution to Canada, France, and Germany.

## Key facts

- **Recall number:** Z-2321-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-30
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2024

## Citation

> AI Analytics. FDA recall Z-2321-2024. Retrieved 2026-09-10 from https://api.ai-analytics.org/recall/Z-2321-2024. Source: US FDA. Licensed CC0.

---

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