MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
FDA Recall #Z-1367-2024 — Class II — February 21, 2024
Product Description
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.
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
585 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UPC 041533341208, Lot Numbers: M053590, M053280
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated