Cardinal Health 200, LLC Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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 .

Recommended Action

Per FDA guidance

Cardinal Health sent an URGENT:MEDICAL DEVICE PRODUCT CORRECTION on 10/03/2022 by overnight mail. The notice explained the issue and requested the following: "Actions Required: 1. COMMUNICATE with all personnel that utilize these gel packs regarding appropriate use. 2. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product correction notice and share a copy of this notice. 3. POST a copy of this notification in your storeroom where the product is stored 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmbfieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product." Additional Information: "For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332."