The Recall Desk
SevereFDA (Devices)·Z-1142-2023·Announced 2023-03-08

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.

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: 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
  • oxygen-deprivation

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.