The Recall Desk
SevereFDA (Devices)·Z-0142-2023·Announced 2022-11-09

Hillrom WatchCare Incontinence System recalled for radio frequency interference risk

Baxter Healthcare is recalling the Hillrom WatchCare Incontinence Management System due to radio frequency emissions that may interfere with other critical medical devices including insulin pumps and fetal monitors.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall. Potential radio frequency interference with critical medical devices such as insulin pumps and fetal monitors poses a significant risk of patient harm, even though no incidents have been reported to date.

Plain-English summary

The Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed (Product Code P00697905) is being recalled by Baxter Healthcare Corporation. The recall affects 814 units distributed in the United States. The device carries FDA Medical Device Listing UDI/DI 887761984998 and includes all serial numbers.

Radio frequency emissions from the WatchCare device may potentially interfere with other medical devices used in hospital settings, including telemetry devices, bladder scanners, fetal monitors and dopplers, infusion pumps, and insulin pumps. Such interference could affect the proper operation of these critical medical devices.

This is an FDA Class I recall. Refer to FDA recall number Z-0142-2023 for additional information.

The recalled product

Product
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Hospital Equipment / Incontinence Management
Hazard
  • radio-frequency-interference
  • device-interference

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 887761984998
  • all serial numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

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