FDA-Device2024-04-03Class II

MediBeads Neck Wrap, Item Number 34320

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
430 units
Manufactured in
1115 Ridgeland Pkwy Ste 101, N/A, Alpharetta, GA, United States
Products
MediBeads Neck Wrap, Item Number 34320

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2024

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