Agency classClass IOur severity:Severe FDA (Devices)·Z-1139-2023·Announced 2023-03-08

Life2000 Ventilator System Recall: Risk of Patient Desaturation

Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.

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: The FDA classified this as Class I, which establishes a minimum severity score of 4 per the rubric rule that FDA Class I recalls never go below 4. Although no illnesses or injuries are reported in the source material, the potential for patient desaturation in a critical care ventilator device represents a serious patient safety risk.

Plain-English summary

Baxter Healthcare Corporation is recalling 4,279 Life2000 Ventilator Systems (REF BT-20-0002 and BT-20-0002A) distributed nationwide.

There is a potential for patient desaturation events (dangerously low blood oxygen levels) to occur in certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. This safety risk prompted an FDA Class I recall classification.

Patients and healthcare facilities using the Life2000 Ventilator System should contact Baxter Healthcare Corporation or the FDA for guidance on this issue. The manufacturer can provide specific information about affected serial numbers and recommended actions.

The recalled product

Product: Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Respiratory Equipment
Hazard: patient-desaturation
hypoxia
Affected units: 4,279

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)

a) REF BT-20-0002
UDI 00887761978089
Serial Numbers: 120370002037
120370001516
120370001522
L2005055-910
120300000056
120370002035
120370001529
120370001518
120370001514
120370001909
120370001971
120360000581
120370001980
120370002002
120380000643
120370001975
120370002042
120370002030

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.

See all 4 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · patient desaturation