Cardinal Health Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws Recall

Check Your Product

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

Reason for Recall

As stated by FDA

A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.

Recommended Action

Per FDA guidance

Cardinal Health issued a "MEDICAL DEVICE PRODUCT ADVISORY" letter and Acknowledgement Form dated 6/9/2021 via overnight mail to the direct consignees on June 09, 2021. Letters states reason for issuance, health risk associated and action to take: The caution statement on the labeling will be updated to remind the user to activate away from face and infant. The full caution statement will now state: Caution: Activate away from face and infant. If pack ruptures or contents leak, flush contact area with water. Discard pack. If redness or irritation persists, consult a physician. What actions are needed from the Customer? Please review this enhanced caution statement with your staff to ensure product activation is performed away from the face and infant. 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. In the event you have experienced quality problems or adverse events related to the products listed above, please contact GMB-CAH-Dist-Domestic@cardinalhealth.com