FDAJanuary 25, 2023device
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
What to do
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
UPCs
00887761978089120370002037120370001516120370001522120300000056120370002035120370001529120370001518120370001514120370001909120370001971120360000581
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.2026-03-24
- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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