FDA-Device2022-11-16Class II
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
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
129412 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0192-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief