Welch Allyn Life2000 Ventilator Battery Charger May Cause Device Inoperability
Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of a critical respiratory support device. The battery charger defect can render the ventilator inoperable, creating significant risk to dependent patients, though no injuries are currently reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 946 Welch Allyn Life2000 Ventilation System units (REF BT-20-0002A) due to a defect in the battery charger. The charger can malfunction in a way that triggers both audible and visual alarms. When activated, these alarms cause the ventilator to become inoperable.
This defect poses a serious risk to patients who depend on these ventilators for respiratory support. The recalled units were distributed nationwide throughout the United States.
Facilities and individuals using affected ventilators should immediately cease use and contact Baxter Healthcare Corporation for repair or replacement instructions. Affected units can be identified by checking the device serial numbers against the complete list provided in the FDA recall notice.
The recalled product
- Product
- Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- battery-charger-failure
- device-inoperability
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 (20)
- UDI/DI 00887761981638
- Serial Numbers: L1903102-017
- L1911019-025
- L2001042-007
- L2001042-016
- L2003015-264
- L2005055-916
- L2006020-163
- L2006020-265
- L2006020-455
- L2006020-499
- L2006020-548
- L2007003-009
- 120190000085
- 120190000090
- 120190000707
- 120190000713
- 120190000714
- 120190000730
- 120210000714
Distribution
Distributed nationwide across the United States.
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