Z-1361-2024 Class II Ongoing
FDA device recall Z-1361-2024 was initiated by Bruder Healthcare Company, LLC on February 21, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1416 units.
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