Hill-Rom PRO+ Mattress Microclimate Management Failure Increases Pressure Ulcer Risk
Baxter Healthcare is recalling 404 Hill-Rom PRO+ 36" mattresses due to performance degradation in their heat and moisture management feature. This failure increases the risk of pressure ulcer development in patients.
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. The failure creates increased risk of pressure ulcers through performance degradation of the heat and moisture management system. No illnesses or injuries have been reported, placing this in the risk-of-harm category per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 404 Hill-Rom PRO+ 36" MRS Surface mattresses (model REF P7924A03) due to a failure mode affecting the mattress's Microclimate Management feature.
The failure can reduce the performance of the heat and moisture management system, which is designed to pull heat and moisture away from the patient. This degradation increases the patient's risk of developing pressure ulcers.
The recalled mattresses were distributed worldwide, including to facilities in multiple US states (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 government-operated facilities.
Healthcare facilities that have received these mattresses should identify units with the listed serial numbers and contact Baxter Healthcare Corporation or the FDA for guidance on repair or replacement.
The recalled product
- Product
- Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 404
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 00887761977884
- Serial numbers: W225BP4122
- W225BP4148
- W225BP4154
- W225BP4155
- W225BP4157
- W225BP4158
- W225BP4161
- W225BP4162
- W225BP4167
- W225BP4170
- W225BP4117
- W225BP4124
- W225BP4126
- W225BP4127
- W225BP4129
- W225BP4130
- W225BP4134
- W225BP4138
- W225BP4139
Distribution
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 →Related recalls
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Same hazard · pressure ulcer risk
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