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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Baxter Healthcare Corporation: Life2000 Ventilators Recalled for Failure to Alarm During Low Gas Pressure

Agency Publication Date: October 22, 2024
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Summary

Baxter Healthcare Corporation is recalling 10,957 Welch Allyn Life2000 Ventilation Systems because the devices may fail to trigger a 'Low Gas Pressure' alarm. This specific defect occurs if the gas source—such as a compressor, oxygen cylinder, or wall source—is not supplied to the ventilator before therapy begins. The recall affects model REF MS-01-0118 running software version 06.08.00.00. Consumers should contact their healthcare provider or the manufacturer immediately to ensure their device is functioning safely.

Risk

If the ventilator fails to sound an alarm when gas pressure is low, a patient may not receive the intended breathing support. This lack of oxygen or ventilation could lead to serious injury or death without the user being alerted to the problem.

What You Should Do

  1. Identify if your device is affected by checking the model number REF MS-01-0118 and software version 06.08.00.00 on your Life2000 Ventilator.
  2. Check the exterior packaging for carton codes BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT-20-0011, or RMS010118CP.
  3. Verify the device label for UDI/DI numbers 00887761978089 or 00815410020537.
  4. Ensure that your pressure gas source, such as the Life2000 compressor, oxygen cylinder, or wall source, is fully connected and active before starting any therapy sessions.
  5. Contact your healthcare provider or Baxter Healthcare Corporation directly for further guidance and technical instructions regarding this software issue.
  6. Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer instructions and healthcare provider consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Welch Allyn Life2000 Ventilation System (Software version 06.08.00.00)
Model / REF:
REF MS-01-0118
BT-20-0002
BT-20-0002A
BT-20-0002AP
BT-20-0007
BT-20-0011
RMS010118CP
UPC Codes:
00887761978089
00815410020537
Lot Numbers:
Software version 06.08.00.00

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95398
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Authorized medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 10,957 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.