Device product
Thermalon Back Wrap, Item Number 24312
Z-1362-2024
Product summary
- Event
- Event 94120
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 193 units
- Official record key
device-enforcement:Z-1362-2024
Official wording
Reason: 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.
Code information: UPC 041533243120, Lot Numbers: M053210, M053580, M055910
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Microbial contamination
growth of mold