Thermalon Eye Compress, Item Number 2434
FDA Recall #Z-1359-2024 — Class II — February 21, 2024
Product Description
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.
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
2400 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UPC 041533243427, Lot Codes: M056410
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated