FDA-Device2022-11-16Class II
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
Cardinal Health 200, LLC
Hazard
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 .
Sold states
nationwide and Canada
Affected count
567475 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2023Don't want to check this manually?
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