BEUDAMED
    FDA Enforcement Class II Terminated

    Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.

    Recall: Z-1872-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1872-2013
    Event ID
    65724
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Precision Dynamics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 14, 2013
    Initiation Date
    July 10, 2013
    Classification Date
    August 2, 2013
    Termination Date
    January 6, 2014
    Address
    27770 Entertainment Dr, Suite 200, Valencia, CA, 91355, United States

    Description

    Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.

    Reason

    PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.

    Code Info

    Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.

    Distribution

    US Distribution including the states of SC, TX, TN, WA, OK.

    Quantity

    1,200 pens