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Recall

Class I — Baxter Healthcare Corporation

Recalling firmBAXTER HEALTHCARE CORPORATION
Registered facilityView this company's 32 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusOngoing
ReasonThere is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
ProductLife2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Quantity135 units
DistributionNationwide
Initiated2023-01-25
Classified2023-02-24
Recall numberZ-1140-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Baxter Healthcare Corporation (Z-1140-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91506/

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