FDA Enforcement
Class II
Ongoing
MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
Recall: Z-1367-2024
·
Reported April 3, 2024
Enforcement
- Recall Number
- Z-1367-2024
- 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
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.
Code Info
UPC 041533341208, Lot Numbers: M053590, M053280
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
585 units