The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1417-2022·Announced 2022-07-27

Hill-Rom Centrella Pro+ surface mattress microclimate management feature failure

Baxter Healthcare is recalling Hill-Rom Centrella Pro+ surface mattresses due to a potential Microclimate Management feature failure that may increase the risk of pressure ulcer development.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II medical device recall for a feature that reduces heat and moisture management, increasing patient risk of pressure ulcers. No reported illnesses or injuries are documented in the source material; the hazard is potential rather than documented.

Plain-English summary

Baxter Healthcare Corporation is recalling Hill-Rom Centrella Pro+ 40-inch Surface mattresses (REF P7923A04) due to a potential failure in the Microclimate Management feature. This feature is designed to pull heat and moisture away from the patient, helping to maintain optimal microclimate conditions.

The failure mode can reduce the performance of the Microclimate Management feature, resulting in an increased risk of pressure ulcer development. No illnesses or injuries related to this issue have been reported in the available source material.

The recall affects 9 mattresses with the following serial numbers: W238BP4349, W238BP4350, W238BP4352, W238BP4354, W238BP4355, W238BP4356, W238BP4357, W238BP4358, and W238BP4359. These units were distributed nationwide in the United 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), Canada, and internationally.

Healthcare facilities and patients using these mattresses should be aware of this recall. For guidance on inspecting the affected device, addressing the feature malfunction, or obtaining a replacement, contact Baxter Healthcare Corporation or refer to the FDA's official recall notice (FDA Recall Number Z-1417-2022).

The recalled product

Product
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Hospital Equipment
Hazard
Affected units
9

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 (10)

  • UDI 00887761977914
  • Serial numbers: W238BP4349
  • W238BP4350
  • W238BP4352
  • W238BP4354
  • W238BP4355
  • W238BP4356
  • W238BP4357
  • W238BP4358
  • and W238BP4359.

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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