Baxter's smart incontinence pad recall is Class I - Mass Device

The WatchCare strategy is simply a astute incontinence pad that integrates into healthcare installation bed. [Image courtesy of Baxter]

The FDA issued a announcement declaring the Baxter (NYSE:BAX) WatchCare incontinence absorption strategy (IMS) callback arsenic Class I, the astir superior kind.

Baxter last period issued an urgent aesculapian instrumentality correction for the WatchCare IMS. The strategy appears to radiate radiofrequency (RF) that whitethorn impact different devices connected caregivers and patients. The database of perchance affected devices includes infusion/insulin pumps, humor glucose sensors, fetal monitors/dopplers, telemetry devices and bladder scanners.

Other third-party aesculapian devices whitethorn beryllium affected, too, according to the FDA notice. RF interference could origin erroneous readings oregon malfunctions of the devices connected some patients and staff.

Baxter reported 96 complaints of RF interference. To date, each cases but 2 experienced interference astatine a region little than 1 meter. The institution said it has insufficient information connected region for the 2 remaining reported interferences. It received nary reports of superior injuries oregon deaths related to the issue.

The institution distributed the affected products betwixt Aug. 1, 2018, and Sept. 1, 2022. To date, it recalled 8,550 devices successful the U.S. since initiating the callback connected Sept. 30, 2022.

WatchCare IMS includes circumstantial Centrella, Progressa, and VersaCare infirmary beds and disposable incontinence pads. It discreetly alerts the caregiver of an incontinence event. Its accustomed uses see captious attraction and medical/surgical settings, arsenic good arsenic successful different objective areas.

The affected merchandise models include:

•  P7900B Centrella Bed with WatchCare
• P00697901: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. A-J
• P00697902: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. K
• P00697903: Hospital Bed Accessory, WatchCare System for Progressa Bed
• P00697905: Hospital Bed Accessory WatchCare System for Centrella Bed