The Recall Desk
HighFDA (Devices)·Z-1415-2022·Announced 2022-07-27

Medical Bed Mattress Microclimate Failure Increases Pressure Ulcer Risk

Affected Hill-Rom Centrella Pro+ hospital mattresses can fail to properly manage heat and moisture removal, increasing the risk of pressure ulcer development in patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall affects a patient safety feature with no reported illnesses to date. It qualifies as High severity because it represents a risk-of-harm product where potential serious injury (pressure ulcers) has not yet been reported, fitting the criteria for score 3.

Plain-English summary

Hill-Rom Centrella Pro+ 36" hospital mattresses with specific serial numbers are being recalled by manufacturer Baxter Healthcare Corporation due to a potential failure in the microclimate management system.

The microclimate management feature is designed to pull heat and moisture away from patients lying on the mattress. A failure in this system can reduce its effectiveness, increasing the risk that patients will develop pressure ulcers, which are serious skin and tissue injuries.

The recall affects 136 mattresses distributed across the United States, Canada, and some government facilities. Healthcare providers should identify affected units using the specific serial numbers provided in the recall notice.

Affected healthcare facilities should immediately contact Baxter Healthcare Corporation regarding the recalled mattresses. Do not continue using affected units until they have been repaired or replaced.

The recalled product

Product
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Manufacturer
Baxter Healthcare Corporation
Hazard
  • pressure-ulcer-risk
  • microclimate-failure

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 (20)

  • UDI 00887761977945
  • Serial numbers: W238BP4338
  • W238BP4339
  • W238BP4340
  • W238BP4341
  • W238BP4342
  • W238BP4344
  • W238BP4345
  • W238BP4347
  • W238BP4348
  • W355BP6966
  • W355BP6978
  • W355BP6979
  • W355BP6980
  • W355BP6981
  • W355BP6982
  • W355BP6986
  • W355BP6987
  • W355BP6988
  • W355BP6989

Distribution

Distributed nationwide across the United States.