Life2000 Ventilator poses oxygen desaturation risk with oxygen concentrators
The FDA recalls Baxter's Life2000 Ventilator due to potential patient desaturation when connected to an oxygen concentrator. Affects 71 units nationwide.
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 recall of a critical life-support medical device. Although no illnesses or injuries have been reported, the Class I classification indicates serious potential for adverse health consequences including patient desaturation during ventilatory support.
Plain-English summary
The FDA is recalling the Life2000 Ventilator, manufactured by Baxter Healthcare Corporation, due to a potential risk of patient desaturation events when the device is connected to an oxygen concentrator. Desaturation is a dangerous drop in blood oxygen levels that can occur in affected units under certain operating scenarios.
This recall affects 71 Life2000 Ventilator units distributed nationwide. The affected devices are identified by reference number MS-01-0118 and UDI 00887761978089. Specific affected serial numbers have been documented by the FDA and the manufacturer.
No illnesses or injuries have been reported in association with this hazard to date. However, the potential for serious patient harm from oxygen desaturation during ventilatory support has prompted the FDA's Class I recall classification.
The recalled product
- Product
- Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 71
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 00887761978089
- Serial Numbers: L1912010-050
- L1905010-081
- L1912010-037
- L1903102-024
- L1912025-024
- L1903103-011
- L1911019-026
- L1912013-045
- L1912013-036
- L1905010-028
- L1903102-028
- L1905010-089
- L1912013-019
- L1903102-010
- L1903103-026
- L1905010-058
- L1903097-007
- L1903103-003
- L1905010-092
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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