FDA Enforcement
Class II
Ongoing
Thermalon Back Wrap, Item Number 24312
Recall: Z-1362-2024
·
Reported April 3, 2024
Enforcement
- Recall Number
- Z-1362-2024
- Event ID
- 94120
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Bruder Healthcare Company, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 3, 2024
- Initiation Date
- February 21, 2024
- Classification Date
- March 22, 2024
- Address
- 1115 Ridgeland Pkwy Ste 101, N/A, Alpharetta, GA, 30004-8409, United States
Description
Thermalon Back Wrap, Item Number 24312
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.
Code Info
UPC 041533243120, Lot Numbers: M053210, M053580, M055910
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
193 units