BEUDAMED
    FDA Enforcement Class II Terminated

    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings

    Recall: Z-1036-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1036-2016
    Event ID
    73237
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Action Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 9, 2016
    Initiation Date
    February 3, 2016
    Classification Date
    March 2, 2016
    Termination Date
    June 28, 2016
    Address
    25 Heywood Rd, N/A, Arden, NC, 28704-9302, United States

    Description

    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings

    Reason

    Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling

    Code Info

    Kit #73775, Lot 213403

    Distribution

    Nationwide distribution to MO, NE and TX .

    Quantity

    9 cases (180 kits)