BEUDAMED
    FDA Enforcement Class II Terminated

    Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

    Recall: Z-2234-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2234-2015
    Event ID
    71608
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EXP Pharmaceutical Services Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    February 11, 2015
    Classification Date
    July 24, 2015
    Termination Date
    December 30, 2015
    Address
    48021Warm Springs Boulevard, N/A, Fremont, CA, 94539, United States

    Description

    Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

    Reason

    EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

    Code Info

    OEM Catalog number 9-AVP2-012.

    Distribution

    Distributed in DC and the states of CO, CA, FL, TX, and AR.

    Quantity

    1