Baxter Healthcare Corporation: PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Baxter Healthcare Corporation
- Product
- PRO+ 36" MRS SURFACE, 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: P7924A13
- Reason / hazard
- There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2026-08-18
- Code info
- Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659
- Product quantity
- 824 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Deerfield
- State
- IL
- Country
- United States
- Event id
- 99606
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