FDA-Device2022-11-16Class II
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
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-0187-2023More Cardinal Health 200, LLC recalls
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