Recall Z-1360-2024— 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: Thermalon Sinus Compress (French), Item Number 24332F. 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
Thermalon Sinus Compress (French), Item Number 24332F
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.