Z-0191-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2022
- Initiation Date
- September 28, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 414194 units
Product Description
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
Reason for Recall
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 .
Distribution Pattern
nationwide and Canada
Code Information
All lots