Recall Z-0046-2025— Baxter Healthcare Corporation

Name: FDA recall Z-0046-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-12

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-09-12. It names one FDA 510(k) clearance: K170037. Product: Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP. Reason: The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2024-09-12
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

Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

Reason for recall

The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.

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