BEUDAMED
    FDA Recall Terminated

    Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection

    Recall: Z-1299-2015 · Initiated January 26, 2015

    Recall

    Recall Number
    Z-1299-2015
    Event Number
    70286
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    IMD
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    January 26, 2015
    Posted
    March 19, 2015
    Terminated
    June 14, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection

    Reason

    Products without expiration date have the remote potential for minor burn

    Action

    CooperSurgical issued Recall Notification letter on January 26, 2015, via Fedex confirmed receipt delivery, to all affected customers. Customers were requested to review inventory and return/destroy product that does not have a expiration and lot number. A fax back form to be returned. Customers with questions should call 203.601.5200. CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.

    Quantity

    8865584 units