Recall Z-1363-2024 ยท IMA Pack, Heat, Moist
Bruder Healthcare Company, LLC
Thermalon Neck Wrap, Item Number 24322
| Date | Mar 22, 2024 (initiated Feb 21, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 471 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.