FDA recall Z-1359-2024

Bruder Healthcare Company, LLC · Class II · device

Product

Thermalon Eye Compress, Item Number 2434

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status: Ongoing
Initiation date: 2024-02-21
Report date: 2024-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Alpharetta, GA, United States

Primary source

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