BEUDAMED
    FDA Enforcement Class II Terminated

    bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    Recall: Z-0503-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0503-2018
    Event ID
    78789
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver-Visitec International Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 7, 2018
    Initiation Date
    November 3, 2017
    Classification Date
    February 1, 2018
    Termination Date
    May 31, 2023
    Address
    411 Waverley Oaks Rd Ste 229, Waltham, MA, 02452-8422, United States

    Description

    bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    Reason

    The protective shield was retracted, and the blade was exposed.

    Code Info

    Batch Numbers: 3180336 3181395 3183925 3184461 3183518 3187183 3187940 3189616 3190463 3192521 3193360 3194101 3199801 3200589 3201368 3201959 3202091 3202764 3203228 3204381 3205075 3205511 3205828 3207499 3208102 3211276 3215327 3218819 3218144 3220074 3221091 3221092 3223818 3223055 3223115 3224020 3225234

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey

    Quantity

    123,240 units