BEUDAMED
    FDA Enforcement Class II Terminated

    Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    Recall: Z-2494-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2494-2018
    Event ID
    80288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    June 11, 2018
    Classification Date
    July 18, 2018
    Termination Date
    August 17, 2020
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States

    Description

    Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    Reason

    The suction valve may not close properly which could cause continuous suction.

    Code Info

    Lot numbers 71725, 81743, 91722, and 101723.

    Distribution

    Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

    Quantity

    A total of 63,020 valves were distributed. Specific product quantities were not provided.