BEUDAMED
    FDA Recall 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 · Initiated July 10, 2013

    Recall

    Recall Number
    Z-1872-2013
    Event Number
    65724
    Firm
    Precision Dynamics Corporation
    FEI Number
    2020282
    Product Code
    FZZ
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    July 10, 2013
    Posted
    August 2, 2013
    Terminated
    January 6, 2014
    Address
    27770 Entertainment Dr, Suite 200, Valencia, CA, 91355

    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.

    Action

    Precision Dynamics Corp. (PDC) sent a Urgent: Skin Marker Pen Recall letter dated July 10, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. All affected customers have also been contacted by phone and email as of July 12, 2013 We want to take every precaution to ensure patient safety. 1. Immediately examine your inventory 2. Quarantine the product subject to recall 3. Complete and return the enclosed response form as soon as possible Your PDC Healthcare customer service representative will contact you directly to arrange the return of the product. In addition, if you may have distributed this product, please identify your customers and notify them at once of this product recall. Your customer notification may be enhanced by including a copy of this recall notification letter. If you have any questions please call the PDC Healthcare Returns Department at 800-435-4242 ext. 5003. Thank you for your understanding and assistance related to this matter.

    Distribution

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

    Quantity

    1,200 pens