The recall is in response to issues with the dongle failing to charge the device’s internal battery. Oxygen desaturation can occur when damage to the dongle affects battery charge, putting patients who require ventilator support at risk, according to a news release from the FDA.
“Baxter has received one serious injury complaint potentially related to this issue,” the release said.
Life2000 ventilators under the recall were distributed in the U.S. between Aug. 21 and April 2 with an MS01-0118 product code.
Baxter has reached out to affected customers with instructions on how to identify damage and contact customer service for replacement ventilators if necessary, according to the release.
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