Medical Device Recall: Hill-Rom PRO+ Mattress Microclimate Feature Failure
Hill-Rom PRO+ mattresses are being recalled for a Microclimate Management feature failure that could increase pressure ulcer risk in patients. The recall affects 200 units distributed in the US 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: FDA Class II medical device recall affecting vulnerable hospital patients. No reported illnesses or injuries, but the device failure reduces the microclimate management feature's performance, increasing the risk of pressure ulcer development.
Plain-English summary
The Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress (REF P7924A01 and P7924ARENT01) is subject to a recall due to a device failure that affects its Microclimate Management feature.
This feature is designed to pull heat and moisture away from the patient to help prevent pressure ulcers. When the failure occurs, the feature's performance can be reduced, potentially increasing the patient's risk of pressure ulcer development.
Approximately 200 affected mattresses have been distributed worldwide, including across 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) and in Canada. Specific serial numbers of affected units are available from the manufacturer.
Healthcare facilities using any of the affected mattresses should contact Baxter Healthcare Corporation, the manufacturer, to address the failure mode and arrange for inspection, repair, or replacement of the affected devices.
The recalled product
- Product
- Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- microclimate-management-failure
- pressure-ulcer-risk
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)
- REF P7924A01
- UDI 00887761977907
- Serial numbers: W218BP4042
- W218BP4054
- W218BP4056
- W218BP4059
- W218BP4060
- W218BP4061
- W218BP4058
- W218BP4048
- W218BP4069
- W218BP4053
- W218BP4041
- W218BP4043
- W218BP4044
- W218BP4045
- W218BP4046
- W218BP4049
- W218BP4051
- W218BP4052
Distribution
Distributed nationwide across the United States.
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