DEERFIELD (dpa-AFX) - Baxter International Inc. has issued an urgent medical device recall for Life2000 ventilators citing potential damage to the attached battery charger dongle.
The recall was initiated after the company received reports that the devices are not properly charging when there is damage to the battery charger dongle. Baxter received one serious injury complaint potentially related to the issue.
The Life2000 ventilator with product code MS01-0118 with an attached battery charger dongle has been called back. The impacted ventilators were distributed in the United States between August 21, 2023 and April 2, 2024.
According to the company, damage to the battery charger dongle prevents the ventilator's internal battery from charging. The Life2000 ventilator, if fails to charge or has intermittent charging behavior, may leave the patient unable to use the device.
Inability to use the device for patients requiring ventilator support may result in oxygen desaturation episodes that range from mild to potentially life-threatening.
The company urged patients to always have an alternate means of ventilation or oxygen therapy available.
Baxter has notified the U.S. Food and Drug Administration of its action, and said it is working with customers to replace affected Life2000 ventilator devices.
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