FDA-Device2022-11-16Class II
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
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
1915308 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0185-2023Don't want to check this manually?
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