BEUDAMED
    FDA Enforcement Class II Terminated

    WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.

    Recall: Z-1539-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1539-2018
    Event ID
    79908
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver-Visitec International Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    February 26, 2018
    Classification Date
    April 27, 2018
    Termination Date
    January 28, 2019
    Address
    411 Waverley Oaks Rd Ste 229, N/A, Waltham, MA, 02452-8422, United States

    Description

    WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.

    Reason

    Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.

    Code Info

    Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899

    Distribution

    Distributed to the states of OH, NY, FL, MN, and KS.

    Quantity

    110 total products