Cardinal Health 200, LLC NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.

Recommended Action

Per FDA guidance

Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 06/16/2023 for delivery n 06/19/2023 by FedEx priority overnight. The notice explained the problem, risks, and requested the following: "Actions Required: 1. REVIEW your inventory for the affected product code and lot. Location of product code and lot are shown in above listed table and below example labeling. 2. SEGREGATE and quarantine all affected product upon review of your inventory. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 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."