Device product

Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600

Z-0191-2023

September 28, 2022

Class II

Product summary

Firm: Cardinal Health 200, LLC
Event: Event 90955
Status: Ongoing
Classification: Class II
Quantity: 414194 units
Official record key: device-enforcement:Z-0191-2023

Official wording

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 information: All lots

Distribution pattern: nationwide and Canada

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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 .