BEUDAMED
    FDA Recall 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 · Initiated February 26, 2018

    Recall

    Recall Number
    Z-1539-2018
    Event Number
    79908
    Firm
    Beaver-Visitec International Inc.
    FEI Number
    1211998
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 26, 2018
    Terminated
    January 28, 2019
    Address
    411 Waverley Oaks Rd, Ste 229, Waltham, MA, 02452-8422

    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.

    Action

    On February 26, 2018, Beaver Visitec International Inc. emailed Product Recall Notices to affected customers. The letter identified the affected device and the reason for the recall. Customers were instructed to destroy affected product, provide evidence of the destruction, and complete a customer response form. Customers will receive a credit. Customers with questions regarding the recall may contact Customer Service at (866)906-8080.

    Distribution

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

    Quantity

    110 total products