Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
Baxter Healthcare is recalling 169 PRO+ MRS Mattresses because UDI label errors may lead to incorrect product identification or use with incompatible bed frames.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that may lead to use with an incompatible bed frame, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Baxter Healthcare Corporation is recalling 169 units of the PRO+ MRS SURFACE FOR VERSACARE mattress, Model/Catalog Number P3255A08. The recall is due to an error in the product description on the Unique Device Identification (UDI) label. These discrepancies do not align with the approved product specifications and may lead to incorrect product identification or selection.
The affected units were distributed worldwide, including the United States and Canada. The potential risk is that the labeling error could result in the mattress being used with an incompatible bed frame.
Healthcare facilities and consumers should stop using the affected mattresses and contact Baxter Healthcare Corporation for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P3255A08
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 169
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 (1)
- Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543
Distribution
Distributed nationwide across the United States.
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