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U.S. Department of Health and Human Services

Class 2 Device Recall Bruder Thermalon

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 Class 2 Device Recall Bruder Thermalonsee related information
Date Initiated by FirmFebruary 21, 2024
Date PostedMarch 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1365-2024
Recall Event ID 94120
Product Classification Pack, heat, moist - Product Code IMA
ProductThermalon Stye Compress, Item Number 24352
Code Information UPC 041533243526, Lot Numbers: M058520
Recalling Firm/
Manufacturer		 Bruder Healthcare Company, LLC
1115 Ridgeland Pkwy Ste 101
Alpharetta GA 30004-8409
For Additional Information ContactBruder Customer Care
770-410-0726
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionBruder 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.
Quantity in Commerce24 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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