- The FDA classified Baxter International Inc's BAX recall of hospital bed systems as the most serious type of concern that 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 an incontinence event.
- Baxter warned users about the potential for WatchCare's radio frequencies to interfere with other medical devices.
- The device was found to interfere with other nearby critical devices such as infusion pumps, insulin pumps, blood glucose sensors, and bladder scanners.
- Related: Baxter Q3 Performance underwhelms Investors, FY22 Guidance Lags Consensus.
- The FDA said the interference from WatchCare may lead to erroneous readings or malfunctions on other devices, causing inappropriate medical treatment for patients.
- Baxter recalled 8,550 WatchCare devices distributed between August 1, 2018, and September 1, 2022.
- The FDA said the recall was based on 96 reported complaints of interference with no reports of injuries or death related to the product.
- 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 Baxter acquired in late 2021.
- Price Action: BAX shares closed at $56.30 on Wednesday.
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