PlainRecalls
FDA Devices Moderate Class II Ongoing

Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A

Reported: November 16, 2022 Initiated: September 28, 2022 #Z-0190-2023

Product Description

Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A

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 .

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
649213 units
Distribution
nationwide and Canada
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A. Recalled by Cardinal Health 200, LLC. Units affected: 649213 units.
Why was this product recalled?
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 .
Which agency issued this recall?
This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0190-2023.