Recall Z-1139-2023— Baxter Healthcare Corporation

Name: FDA recall Z-1139-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-25

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-01-25. It names one FDA 510(k) clearance: K170037. Product: Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2023-01-25
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K170037 — Breathe Technologies Life2000 Ventilation SystemBreathe Technologies·cleared 2017-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.