BEUDAMED
    FDA Recall 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 · Initiated July 6, 2015

    Recall

    Recall Number
    Z-2147-2015
    Event Number
    71597
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    MPO
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 6, 2015
    Posted
    July 20, 2015
    Terminated
    June 14, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    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)

    Action

    CooperSurgical sent an " Urgent WarmGel Infant Heel Warmer" letter dated June 30, 2015, FEDEx, confirmed delivery receipt on July 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CooperSurgical is advising all WarmGel users to review your inventory of this product, remove it from your inventory and discontinue its use. informing them of the reason to cease using the product and either discard or return product to CooperSurgical. Accounts are provided with a response form to complete. Any questions contact CooperSurgical at 203 601 5200 Ext. 310

    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