Agency classClass IOur severity:Severe FDA (Devices)·Z-1141-2023·Announced 2023-03-08

Life2000 Hospital Ventilator Recalled for Patient Desaturation Risk

Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.

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, which mandates a minimum severity score of 4 per the rubric. The hazard—potential patient desaturation when connected to an oxygen concentrator—represents a serious patient safety risk to ventilator-dependent patients. However, the source text does not report any deaths, hospitalizations, or confirmed injuries, so the score remains at the Class I floor of Severe (4).

Plain-English summary

The Life2000 Ventilator PKG, Hospital (REF BT200011 and REF BT-20-0011), manufactured by Baxter Healthcare Corporation, is being recalled due to the potential for patient desaturation events to occur when the ventilator system is connected with an oxygen concentrator.

The recall affects 8 units distributed nationwide. Affected serial numbers include L190606-014, L191011-040, L200127-015, L200204-013, L200226-012, L200226-013, and L200226-015.

Healthcare providers and patients using the Life2000 ventilator should be aware of the potential for desaturation events when the device is connected to an oxygen concentrator. Facilities with affected units should contact Baxter Healthcare Corporation for instructions and consult the FDA recall notice for additional information.

This is an FDA Class I recall.

The recalled product

Product: Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Respiratory Equipment
Hazard: patient-desaturation
hypoxia
Affected units: 8

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 (10)

a) REF BT200011
UDI 00887761978089
Serial Numbers: L190606-014
L191011-040
L200127-015
L200204-013
b) REF BT-20-0011
Serial Numbers: L200226-012
L200226-013
L200226-015

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