Welch Allyn Life2000 Ventilator Battery Charger Malfunction Recall
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.
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: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls must be scored no lower than 4. No deaths or serious injuries have been reported. The hazard—a battery charger malfunction that renders a critical life-support device inoperable—qualifies as severe rather than critical.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation System (REF BT-20-0002AP) due to a defect in the ventilator battery charger.
The battery charger can trigger an audible and visual alarm that causes the ventilator to become inoperable. When the alarm engages, the device cannot function to deliver ventilation support.
This recall affects units distributed nationwide in the United States. The affected unit serial number is 122010001081.
If you have a Welch Allyn Life2000 Ventilation System, contact Baxter Healthcare Corporation or the FDA for instructions on replacement or repair of the affected device.
The recalled product
- Product
- Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1
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 00887761981638
- Serial Numbers: 122010001081
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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