Baxter Healthcare recalls Welch Allyn Life2000 Ventilation Systems with specific carton codes and software versions due to potential failure to trigger low gas pressure alarms if gas source isn't connected before use.
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.
Baxter Healthcare is recalling Welch Allyn Life2000 Ventilation Systems with certain carton codes and software versions. These ventilators may fail to sound a low gas pressure alarm if the gas source isn't connected before starting therapy, which could lead to unsafe conditions during medical use.
The ventilator may not activate the low gas pressure alarm if the oxygen source (compressor, cylinder, or wall connection) isn't properly connected before starting therapy. This could result in insufficient oxygen delivery if the system fails to warn the user.
Healthcare providers using Welch Allyn Life2000 Ventilators with specific carton codes and software versions are most at risk. Patients receiving ventilation therapy through these devices could be affected if the system fails to alert to low gas pressure.
Check for carton codes: BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT-20-0011, or RMS010118CP. Also look for software version 06.08.00.00 or UDI/DI numbers 00887761978089 or 00815410020537.
Ensure the oxygen source (compressor, cylinder, or wall connection) is connected before starting therapy to prevent low gas pressure alarm failure.
Life2000 Ventilators with carton codes BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT-20-0011, or RMS010118CP, and software version 06.08.00.00.
Check the carton code on the exterior packaging or the software version on the device. Affected units have specific carton codes or UDI/DI numbers listed in the recall notice.
Ensure the oxygen source is connected before starting therapy to prevent low gas pressure alarm failure. The recall does not require immediate removal but requires proper setup to avoid risks.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-0046-2025 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-0046-2025 from Welch Allyn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
