BEUDAMED
    FDA Recall Terminated

    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.

    Recall: Z-1572-2013 · Initiated May 14, 2013

    Recall

    Recall Number
    Z-1572-2013
    Event Number
    65417
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    FGY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 14, 2013
    Posted
    June 21, 2013
    Terminated
    September 18, 2014
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.

    Reason

    The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.

    Action

    Maquet sent an "Urgent Product Recall"/"Recall - Device Corrective Action Response" forms dated May 14, 2013, via Federal Express to all affected customers. The notification identifies affected product; informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; and advises customers to follow instructions on the "Recall-Device Corrective Action Response" forms included as part of the notification. If you have any further questions please contact your local MAQUET representative or call Customer Service at (888) 627-8383.

    Distribution

    Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.

    Quantity

    100 units (60 Domestic; 40 International)