FDA recall Z-1367-2024

Bruder Healthcare Company, LLC · Class II · device

Product

MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R

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-1367-2024