The Recall Desk
HighFDA (Devices)·Z-1413-2022·Announced 2022-07-27

Hill-Rom Mattress Microclimate Feature Failure Increases Pressure Ulcer Risk

Certain Hill-Rom PRO+ MRS mattresses may have a Microclimate Management feature failure that increases patient pressure ulcer risk. Affected units were distributed to 25+ U.S. states and Canada.

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 with no reported hospitalizations, deaths, or illnesses. The hazard represents theoretical increased risk of pressure ulcer development without documented injury cases. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Baxter Healthcare Corporation is recalling 8 Hill-Rom PRO+ MRS Surface mattresses for Versacare With X-Ray (REF P3255A01), identified by UDI 00887761977860 and eight specific serial numbers.

The Microclimate Management feature is designed to pull heat and moisture away from patients, reducing the risk of pressure ulcers. The affected mattresses have a failure mode that reduces the performance of this feature, increasing patient risk of pressure ulcer development.

The mattresses were distributed nationwide across 25 U.S. states including Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont, and Wisconsin, as well as in Canada.

The recalled product

Product
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
Manufacturer
Baxter Healthcare Corporation
Hazard
  • pressure-ulcer-risk
  • microclimate-management-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 (9)

  • UDI 00887761977860
  • Serial numbers: W214BP3955
  • W214BP3956
  • W243BP4436
  • W243BP4438
  • W243BP4445
  • W243BP4446
  • W243BP4447
  • and W243BP4448.

Distribution

Distributed nationwide across the United States.