Life2000 Ventilator May Fail to Alarm on Low Gas Pressure
Baxter Healthcare recalls Life2000 Ventilators due to potential Low Gas Pressure alarm failure. The alarm may not activate if the gas source isn't connected before therapy begins.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification mandates a minimum severity score of 4. The hazard—failure of the Low Gas Pressure alarm on a life-support ventilator—poses serious risk to patient safety. No illnesses or deaths have been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation System (approximately 10,957 units) distributed nationwide across the United States.
The Life2000 ventilator contains a potential flaw where the Low Gas Pressure alarm may fail to initiate if the pressure gas source—such as the Life2000 compressor, oxygen cylinder, or wall source—is not already connected and supplied to the ventilator before therapy is initiated.
Healthcare facilities and individuals using affected units should contact Baxter Healthcare Corporation for guidance on device verification and corrective actions.
The recalled product
- 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
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 10,957
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00887761978089 or 00815410020537
- All Life2000 Ventilators with software version 06.08.00.00
Distribution
Distributed nationwide across the United States.
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