Highest risk U.S. Food and Drug Administration

Baxter Life2000 Ventilator with an attached battery charger dongle recall: Potential Battery Charger Dongle Damage

Recall published 2+ years ago

Potential Battery Charger Dongle Damage

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Baxter has received one serious injury complaint potentially related to this issue and is working with customers to replace affected Life2000 ventilator devices.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
July 10, 2024
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Baxter
Product type
Medical devices

Products covered by this recall

Life2000 Ventilator with an attached battery charger dongle

What the company announced

DEERFIELD, Ill., July 10, 2024 – Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. Baxter has received one serious injury complaint potentially related to this issue and is working with customers to replace affected Life2000 ventilator devices.

Damage to the battery charger dongle prevents the ventilator’s internal battery from charging. If the Life2000 ventilator fails to charge or has intermittent charging behavior, this may leave the patient unable to use the device. For patients requiring ventilator support, inability to use the device may result in oxygen desaturation episodes that range from mild to potentially life-threatening. Patients should always have an alternate means of ventilation or oxygen therapy available.

Baxter has contacted affected customers, instructing them to inspect the condition of the battery charger dongle and confirm the device is charging properly. If damage is observed or the battery is not charging properly, patients should contact Baxter Home Care Customer Service to have the device replaced immediately. If no damage is observed and the battery is charging properly, patients may continue to use the ventilator and Baxter will replace the device at the patient’s next scheduled in-home visit with a clinical trainer.

The Urgent Medical Device Recall applies to the Life2000 ventilator with product code MS01-0118 with an attached battery charger dongle. The impacted ventilators were distributed in the United States between Aug. 21, 2023 and April 2, 2024.

Baxter has notified the U.S. Food and Drug Administration (FDA) of this action. Any product quality complaints or adverse events experienced with the use of these products may be reported using one of the following options:

Calling Baxter Home Care Customer Service at 800-426-4224, option 3 between the hours of 7:30 a.m. and 6 p.m. central time, or Baxter Clinical Support at 800-397-9071, which is available 24 hours a day.

Reporting to the FDA MedWatch Serious Injury Reporting Program:

Online: By completing and submitting the report online at: https://www.accessdata.fda.gov/scripts/medwatch/ o Regular mail or fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.

Media Contact

Natalie Matthews, (224) 515-0219

[email protected]

Investor Contact

Clare Trachtman, (224) 948-3020

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • MS01-0118

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Baxter — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Baxter International, Inc. — Consumers: Baxter Home Care Customer Service, 800-426-4224, option 3 — Media: Natalie Matthews, (224) 515-0219, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Baxter medical devices recalled?

Potential Battery Charger Dongle Damage Baxter has received one serious injury complaint potentially related to this issue and is working with customers to replace affected Life2000 ventilator devices.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number MS01-0118. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Related recalls