Z-1361-2024 Class II Ongoing

Recalled by Bruder Healthcare Company, LLC — Alpharetta, GA

Recall Details

Product Type
Devices
Report Date
April 3, 2024
Initiation Date
February 21, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1416 units

Product Description

Thermalon Sinus Compress, Item Number 24332

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 Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

UPC 041533243328, Lot Numbers: M053160, M053570