FDA-Device2024-04-03Class II
Thermalon Sinus Compress, Item Number 24332
Bruder Healthcare Company, LLC
Hazard
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
1416 units
Manufactured in
1115 Ridgeland Pkwy Ste 101, N/A, Alpharetta, GA, United States
Products
Thermalon Sinus Compress, Item Number 24332
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1361-2024Don't want to check this manually?
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