BEUDAMED
    FDA Enforcement Class III 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 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1025-2013
    Event ID
    64075
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viscot Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    August 22, 2012
    Classification Date
    March 29, 2013
    Termination Date
    July 21, 2014
    Address
    32 West St, N/A, East Hanover, NJ, 07936-2822, United States

    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.

    Code Info

    Lot# 022043, 022045, 022046, 042084, 042085, 042086, 042087, 042088, 042089, 052128, 052129, 052130, 052131, 062167, 062168, 062169, 062170, 072200, 072201, 072203, 072205, 072206, 072207 (Including any letter suffixes after lot #).

    Distribution

    USA Nationwide Distribution

    Quantity

    458,589 markers