FDA classifies Baxter’s hospital bed system recall as most serious type

November 28 – The U.S. Food and Drug Administration (FDA) has classified the recall of hospital bed systems by Baxter International Inc., as the most serious type, on concerns it could lead to life-threatening injuries or death. The device was found to interfere with other nearby critical devices such as infusion pumps, insulin pumps, blood glucose sensors and bladder scanners, among others.

Baxter in late September initiated the recall of its WatchCare Incontinence Management System, which is used to discreetly alert an incontinent patient’s caregiver of involuntary urination or defecation.

In a letter sent to customers, Baxter warned users about the potential for WatchCare’s radio frequencies to interfere with other medical devices. The correction letter was updated last month to include actions healthcare practitioners could undertake in case they encountered any malfunction or interference.

The Food and Drug Administration said the interference from WatchCare may lead to erroneous reading or malfunctions on other devices, causing inappropriate medical treatment for patients. The recall was based on 96 reported complaints of interference with no reports of injuries or death related to the product. Many of the recalled WatchCare devices were manufactured by Hillrom, which was acquired by Baxter in late 2021.

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