Baxter International Inc. has announced an urgent recall of its Life2000 ventilators due to potential damage to the accompanying battery charger dongle.
This recall follows reports indicating the devices may fail to charge correctly when the battery charger dongle is compromised. One serious injury complaint potentially linked to this issue has been reported.
The recall specifically targets Life2000 ventilators with the product code MS01-0118 that include the affected battery charger dongle. These units were distributed across the United States from August 21, 2023, to April 2, 2024.
Baxter has identified that damage to the battery charger dongle can inhibit the ventilator's internal battery from charging. Consequently, this malfunction could render the ventilator unusable or lead to inconsistent charging, posing a significant risk to users.
For patients reliant on ventilator support, the inability to use their device could result in oxygen desaturation episodes, ranging from mild to potentially life-threatening. The company has advised patients to ensure they have an alternative means of ventilation or oxygen therapy available.
Baxter has informed the U.S. Food and Drug Administration (FDA) of the recall and is working collaboratively with customers to replace the affected Life2000 ventilator devices.
