FDAFDA · Food and drugs·Recall number Z-1360-2024
Thermalon Sinus Compress (French), Item Number 24332F
Published April 3, 2024 · Recall initiated: February 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Bruder Healthcare Company, LLC
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- UPC 041533243328, Lot Numbers: M053600, M053340
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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