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Open, Classified

Thermalon Eye Compress, Item Number 2434

FDA Recall Z-1359-2024 · Posted 2024-03-22

Recalling FirmBruder Healthcare Company, LLC
Recall StatusOpen, Classified
Product CodeIMA
Date Initiated2024-02-21
Product Quantity2400 units

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.

Firm Action

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

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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