BEUDAMED
    FDA Recall Terminated

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    Recall: Z-1025-2013 · Initiated August 22, 2012

    Recall

    Recall Number
    Z-1025-2013
    Event Number
    64075
    Firm
    Viscot Medical LLC
    FEI Number
    2242656
    Product Code
    FZZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 22, 2012
    Posted
    March 29, 2013
    Terminated
    July 21, 2014
    Address
    32 West St, East Hanover, NJ, 07936-2822

    Description

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    Reason

    Dual Tip Marker has inconsistent ink flow on the black permanent ink side.

    Action

    Viscot Medical LLC sent a Customer Notification Letter dated August 22, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to return the affected product for a replacement. To return the product call 1-800-221-0658 or e-mail jeffl@viscot .com for the RGA.

    Distribution

    USA Nationwide Distribution

    Quantity

    458,589 markers