FDA-Device2022-07-27Class II
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
Baxter Healthcare Corporation
Hazard
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.
Affected count
404 mattresses
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2022Don't want to check this manually?
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