Baxter Healthcare Corporation: 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

Hazard

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.

Details from the source

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: US nationwide distribution. Quantity: 10,957 units Lot/code info: UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

UPC codes

00887761978089, 00815410020537

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.