FDAFDA · Food and drugs·Recall number Z-0046-2025
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
Published October 30, 2024 · Recall initiated: September 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US nationwide distribution.
- Lot
- UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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