BEUDAMED
    FDA Enforcement Class II Terminated

    Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

    Recall: Z-2740-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2740-2018
    Event ID
    80565
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver Visitec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    June 18, 2018
    Classification Date
    August 9, 2018
    Termination Date
    October 30, 2019
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

    Reason

    Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.

    Code Info

    Lot Number 6001700

    Distribution

    Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel

    Quantity

    440