BEUDAMED
    FDA Enforcement Class II Terminated

    Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

    Recall: Z-1952-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1952-2014
    Event ID
    68564
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Action Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 9, 2014
    Initiation Date
    June 12, 2014
    Classification Date
    July 1, 2014
    Termination Date
    February 3, 2015
    Address
    25 Heywood Rd, Arden, NC, 28704-9302, United States

    Description

    Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

    Reason

    Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

    Code Info

    Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.

    Distribution

    Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

    Quantity

    474 cs (9,480 ea) total for all kits involved