BEUDAMED
    FDA Enforcement Class II Terminated

    GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

    Recall: Z-1250-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1250-2017
    Event ID
    76363
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    January 12, 2017
    Classification Date
    February 23, 2017
    Termination Date
    April 18, 2018
    Address
    6464 Sycamore Ct N, N/A, Maple Grove, MN, 55369-6032, United States

    Description

    GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

    Reason

    Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.

    Code Info

    Lot Numbers: 581212, 584392, 594115, 597202

    Distribution

    US Nationwide Distribution in the states of NH, ME, VT, NY, LA, MS, AL CA, IA, WA, OR, MD, DE, PA, NJ, ID, TX, OK, MO, WI, GA, FL, AR, OH, AZ.

    Quantity

    633