FDA Enforcement
Class II
Ongoing
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
Recall: Z-0187-2023
·
Reported November 16, 2022
Enforcement
- Recall Number
- Z-0187-2023
- Event ID
- 90955
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 16, 2022
- Initiation Date
- September 28, 2022
- Classification Date
- November 7, 2022
- Address
- 3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States
Description
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
Reason
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Code Info
All lots
Distribution
nationwide and Canada
Quantity
567475 units