# FDA recall Z-0046-2025

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2024-09-12.

## Product

Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes:  1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

## Reason for recall

The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-0046-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-12
- **Report date:** 2024-10-30

- **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-0046-2025

## Citation

> AI Analytics. FDA recall Z-0046-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0046-2025. Source: US FDA. Licensed CC0.

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