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.
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: 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
- Hazard
- patient-desaturation
- equipment-malfunction
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.
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