BEUDAMED
    FDA Recall Open, Classified

    NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

    Recall: Z-2147-2023 · Initiated June 16, 2023

    Recall

    Recall Number
    Z-2147-2023
    Event Number
    92529
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    MPO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 16, 2023
    Posted
    July 17, 2023
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

    Reason

    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.

    Action

    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 [email protected], 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: [email protected] or call 800-292-9332."

    Distribution

    US Nationwide distribution.

    Quantity

    44,500 units