www.fdanews.com/articles/213889-baxter-life2000-ventilator-systems-see-class-i-recall-related-to-battery-charger-damage
Baxter Life2000 Ventilator Systems See Class I Recall Related to Battery Charger Damage
July 3, 2024
Baxter Healthcare’s Life2000 ventilator system is subject to a Class I recall for the potential of the device to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle which can prevent charging, the FDA said.
The company sent letters to customers around May 29 to ensure patients always have an alternate means of ventilator or oxygen therapy available.
The company also requested that customers inspect the battery charger dongle for damage and replace immediately if damaged. The FDA’s notice said that “Baxter will replace their ventilator device upon their next scheduled in-home visit with a clinical trainer.”
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