BEUDAMED
    FDA Enforcement Class II Completed

    Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery

    Recall: Z-2010-2015 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-2010-2015
    Event ID
    71130
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Stradis Healthcare, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    April 20, 2015
    Classification Date
    July 7, 2015
    Address
    805 Marathon Pkwy Ste 100, N/A, Lawrenceville, GA, 30046-2885, United States

    Description

    Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery

    Reason

    Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

    Code Info

    Pack 693-210, 693-054, 693-219, 888-2479, 888-2499

    Distribution

    Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

    Quantity

    5