BEUDAMED
    FDA Enforcement Class I Terminated

    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

    Recall: Z-2096-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2096-2016
    Event ID
    74301
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2016
    Initiation Date
    June 1, 2016
    Classification Date
    July 21, 2016
    Termination Date
    October 19, 2016
    Address
    1810 W Drake Dr, N/A, Tempe, AZ, 85283-4327, United States

    Description

    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

    Reason

    Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

    Code Info

    Item Lot Manufacturing Number Number Date Expiration Date 10732203 119965U 11/7/2003 N/A 10732203 158623U 12/2/2003 N/A 10732203 175183U 3/22/2005 N/A 10732203 179688U 10/29/2004 N/A 10732203 191185U 12/5/2004 N/A 10732203 210813U 7/1/2005 N/A 10732203 225911U 10/27/2005 N/A 10732203 225918U 10/19/2005 N/A 10732203 225919U 10/17/2005 N/A 10732203 8248U 1/31/2006 N/A 10732203 253202U 2/23/2006 N/A 10732203 277726U 7/21/2006 N/A 10732203 302844U 12/14/2006 N/A 10732203 309329U 11/16/2006 N/A 10732203 325680U 12/30/2006 N/A 10732203 343908U 8/2/2008 N/A 10732203 352756U 8/11/2008 N/A 10732203 352761U 9/3/2008 N/A 10732203 359352U 2/6/2008 N/A 10732203 363987U 5/17/2008 N/A 10732203 366572U 10/18/2008 N/A 10732203 369818U 9/27/2008 N/A 10732203 375883U 9/20/2008 N/A 10732203 772102U 8/5/2004 N/A 10732203 773196U 12/18/2004 N/A 10732203 773216U 1/6/2005 N/A 10732203 775985U 3/16/2005 N/A 10732203 7710750U 8/3/2006 N/A

    Distribution

    Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.

    Quantity

    167