BEUDAMED
    FDA Enforcement Class II Terminated

    Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX

    Recall: Z-2147-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2147-2015
    Event ID
    71597
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    July 6, 2015
    Classification Date
    July 20, 2015
    Termination Date
    June 14, 2016
    Address
    75 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX

    Reason

    Product marketed without a 510(k)

    Code Info

    All lot numbers

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.

    Quantity

    6,344,700