FDA recall Z-0191-2023

Product

Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600

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 .

Distribution

nationwide and Canada

Key facts

Status

Ongoing

Initiation date

2022-09-28

Report date

2022-11-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0191-2023