The Recall Desk
HighFDA (Devices)·Z-1414-2022·Announced 2022-07-27

Hill-Rom Hospital Mattress Surfaces Recalled for Pressure Ulcer Risk

Baxter Healthcare is recalling 202 Hill-Rom PRO+ mattress surfaces. The microclimate management feature may malfunction, reducing the product's ability to manage heat and moisture, which increases the risk of patient pressure ulcers.

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 is an FDA Class II recall of a medical device where an identified failure mode creates increased patient risk of pressure ulcer development, but no illnesses or injuries have been reported. This meets the criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling 202 Hill-Rom PRO+ MRS Surface hospital mattresses, model REF P3255A02. These mattress surfaces are used in healthcare settings to provide pressure relief and manage patient temperature and moisture.

The recall is issued because of a failure mode that can reduce the effectiveness of the microclimate management feature. When this feature fails, it cannot properly pull heat and moisture away from the patient, increasing the risk of pressure ulcer development.

The affected mattresses were distributed nationwide across 27 US states (AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI), in Canada, and to US government facilities. Specific affected serial numbers are listed in FDA recall notice Z-1414-2022.

Healthcare facilities with affected mattress surfaces should consult the full FDA recall notice for information regarding remediation and next steps.

The recalled product

Product
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
Manufacturer
Baxter Healthcare Corporation
Hazard
  • pressure-ulcer-risk
  • device-malfunction

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 00887761977853
  • Serial numbers: W236BP4315
  • W236BP4320
  • W236BP4326
  • W235BP4284
  • W235BP4294
  • W236BP4318
  • W236BP4319
  • W236BP4323
  • W236BP4325
  • W236BP4331
  • W236BP4333
  • W236BP4334
  • W236BP4336
  • W235BP4270
  • W235BP4271
  • W235BP4272
  • W235BP4278
  • W235BP4279
  • W235BP4287

Distribution

Distributed nationwide across the United States.