BEUDAMED
    FDA Enforcement Class II Terminated

    ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

    Recall: Z-1145-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1145-2013
    Event ID
    64840
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acist Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 15, 2013
    Classification Date
    April 18, 2013
    Termination Date
    August 7, 2013
    Address
    7905 Fuller Rd, N/A, Eden Prairie, MN, 55344-2137, United States

    Description

    ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

    Reason

    ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w

    Code Info

    23884007, 23884008, 23884009

    Distribution

    Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.

    Quantity

    6640 units