Agency classClass IOur severity:Severe FDA (Devices)·Z-1140-2023·Announced 2023-03-08

Life2000 Hospital Ventilator Recalled for Potential Patient Desaturation Risk

Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when 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: FDA Class I medical device recall with potential for serious patient harm through desaturation. The agency's Class I classification mandates a minimum severity of 4 per the rubric, though no deaths or serious injuries are reported in the source text.

Plain-English summary

Baxter Healthcare Corporation is recalling the Life2000 Ventilator PKG, Hospital model nationwide. The recall affects 135 units with reference numbers REF BT20007 and REF BT-20-0007, identified by specific serial numbers documented by the FDA.

The recall was issued due to the potential for patient desaturation events when the Life2000 ventilation system is connected with an oxygen concentrator. Desaturation—a drop in blood oxygen levels—can occur under certain operational scenarios and poses a serious risk to patients receiving respiratory support.

Healthcare facilities using the Life2000 Ventilator should verify whether they have units matching the recalled serial numbers. Facilities with affected devices should contact Baxter Healthcare Corporation and the FDA for guidance on repair, replacement, or removal from service.

The recalled product

Product: Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Hospital Respiratory Equipment
Hazard: patient-desaturation
equipment-malfunction
Affected units: 135

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 BT20007
UDI 00887761978089
Serial Numbers: L191001-005
L191001-003
L191001-004
L191001-002
L191001-001
L191212-022
L191212-023
L191212-021
L191212-024
L191212-025
L200114-011
L200114-004
L200114-008
L1911019-015
L1911019-021
L1911019-023
b) REF BT-20-0007
Serial Numbers: L1911019-016

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