Home / Recalls / Baxter Healthcare Corporation / Z-0046-2025

Z-0046-2025 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
September 12, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,957 units

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.

Distribution Pattern

US nationwide distribution.

Code Information

UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

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  • D-0296-2026 Class II — Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte (December 22, 2025)
  • Z-1121-2026 Class II — SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 (November 28, 2025)
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  • Z-0203-2026 Class II — CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and C (August 29, 2025)
  • Z-0195-2026 Class II — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CL (August 29, 2025)
  • Z-0190-2026 Class II — CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drop (August 29, 2025)