BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2147-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2147-2023
    Event ID
    92529
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    June 16, 2023
    Classification Date
    July 17, 2023
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    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.

    Code Info

    UDI/DI (Case) 50885380057586, (Box) 20885380057585, (EA) 10885380057588, Lot Number V2S056

    Distribution

    US Nationwide distribution.

    Quantity

    44,500 units