Recall Z-0187-2023— Cardinal Health 200, LLC

Name: FDA recall Z-0187-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-28

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2022-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304. Reason: 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 ..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-09-28
Firm location: Waukegan, IL, United States

Product description

Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304

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 .

Data sourced from openFDA. This site is unofficial and independent of the FDA.