CLASS I ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Welch Allyn Life2000 Ventilation System recalled by Baxter Healthcare
Baxter Healthcare is recalling Welch Allyn Life2000 Ventilation System, distributed nationwide in the US. The recall was initiated on 12 Sep 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0046-2025
- FDA event ID
- 95398
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Sep 2024
- FDA classified
- 22 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 12 Sep 2024 | Recall initiated by company | |
| 22 Oct 2024 | Classified by FDA | +40 days |
| 30 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00
Where was it sold?
US nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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