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Recall Observatory FDA recall evidence

Device product

Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

Z-1141-2023

January 25, 2023

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 91506
Status
Ongoing
Classification
Class I
Quantity
8 units
Official record key
device-enforcement:Z-1141-2023

Official wording

Reason: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.