BEUDAMED
    FDA Enforcement Class II Terminated

    DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

    Recall: Z-2764-2017 · Reported August 2, 2017

    Enforcement

    Recall Number
    Z-2764-2017
    Event ID
    77641
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 2, 2017
    Initiation Date
    June 22, 2017
    Classification Date
    July 25, 2017
    Termination Date
    July 22, 2020
    Address
    7611 Northland Dr N, N/A, Brooklyn Park, MN, 55428-1088, United States

    Description

    DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

    Reason

    Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

    Code Info

    Model No. 11001G; Product UPN 20613994918554; Lot No. 2016020769, 2016030796, 2016040778, 2016060872, 2016061425, 2016070500, 2016081190, 2016090516, 2016091016, 2016110504, 2016120414, 2017010236, 2017011281, 2017030506.

    Distribution

    Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.

    Quantity

    63053 (48180 US) (14873 OUS)