Thermalon Sinus Compress (French), Item Number 24332F
FDA Recall #Z-1360-2024 — Class II — February 21, 2024
Product Description
Thermalon Sinus Compress (French), Item Number 24332F
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.
Recalling Firm
Bruder Healthcare Company, LLC — Alpharetta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2160 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UPC 041533243328, Lot Numbers: M053600, M053340
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated