Device product

Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A

Z-0192-2023

September 28, 2022

Class II

Product summary

Firm: Cardinal Health 200, LLC
Event: Event 90955
Status: Ongoing
Classification: Class II
Quantity: 129412 units
Official record key: device-enforcement:Z-0192-2023

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: UDI/DI (01)30888499004898, 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 .