FDA-Device2024-04-03Class II

Thermalon Eye Compress, Item Number 2434

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
2400 units
Manufactured in
1115 Ridgeland Pkwy Ste 101, N/A, Alpharetta, GA, United States
Products
Thermalon Eye Compress, Item Number 2434

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1359-2024

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