FDA classifies Baxter's hospital bed system recall as most serious

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Nov 23 (Reuters) - The U.S. health regulator on Wednesday classified the recall of hospital bed systems by Baxter International Inc (BAX.N), as the most serious type, on concerns it could lead to life-threatening injuries or death.

Baxter 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, by sending a correction letter to its customers in late September.

In the letter, 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 device was found to interfere with other nearby critical devices such as infusion pumps, insulin pumps, blood glucose sensors and bladder scanners, among others.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.

Baxter, which makes smart hospital beds, recalled 8,550 WatchCare devices distributed between Aug. 1, 2018 and Sept. 1, 2022.

The recall was based on 96 reported complaints of interference with no reports of injuries or death related to the product, the FDA said.

Baxter said it has sought location and removal of the device from clinical care areas, where possible.

Many of the recalled WatchCare devices were manufactured by Hillrom, which was acquired by Baxter in late 2021.

(This story has been corrected to fix the company name to Baxter International, from Baxter Hillrom, in the headline and the story and to add the last paragraph to say Hillrom was bought by Baxter)

Reporting by Khushi Mandowara; Editing by Krishna Chandra Eluri

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