FDA Device Recall Z-0143-2023

Baxter Healthcare Corporation · Deerfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.

Lot / serial / GTIN: UDI/DI 00887761998889, all serial numbers

Quantity: 1137 units

Reason for recall

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

Recall record

Recall number: Z-0143-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US
Recall initiated: 2022-09-30
Classified by FDA Center: 2022-10-31
FDA published: 2022-11-09
Recalling firm: Baxter Healthcare Corporation
Firm location: Deerfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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