Recall Z-1367-2024— Bruder Healthcare Company, LLC
Class II · Ongoing
Class II FDA medical device recall by Bruder Healthcare Company, LLC, initiated 2024-02-21. FDA's recall record names no specific 510(k) clearance for this event. Product: MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R. 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..
- Recalling firm
- Bruder Healthcare Company, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-21
- Firm location
- Alpharetta, GA, United States
Product description
MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.