Thermalon Stye Compress, Item Number 24352
FDA device recall Z-1365-2024 · posted 2024-03-22 · Open, Classified
Recall details
- Recalling firm
- Bruder Healthcare Company, LLC
- 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.
- Action taken
- Bruder Healthcare Company sent an email to its consignees on XXX to notify them of the recall. The email explained the issue and requested the consignees cease distribution of affected stock and contact Bruder Healthcare Company for instructions on returning the product. Distributors were directed to forward the recall communication to their customers.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- IMA
- Quantity affected
- 24 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2024-02-21
- Date posted
- 2024-03-22
- Location
- Alpharetta, GA
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