BEUDAMED
    FDA Recall 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 · Initiated January 12, 2017

    Recall

    Recall Number
    Z-1250-2017
    Event Number
    76363
    Firm
    Vascular Solutions, Inc.
    FEI Number
    3002827704
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 12, 2017
    Terminated
    April 18, 2018
    Address
    6464 Sycamore Ct N, Maple Grove, MN, 55369-6032

    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.

    Action

    Consignees were sent on 1/12/2017 a Vascular Solutions "Urgent Medical Device Recall" letter dated January 11th, 2017. The letter identified the problem and product involved in the recall. The letter provided "Your Immediate Action Is Required". This included to remove the product from inventory and to complete and return the VSI's Account Inventory Form to VSIs Customer Service Dept.

    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