BEUDAMED
    FDA Enforcement Class II Terminated

    Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth

    Recall: Z-1664-2014 · Reported June 4, 2014

    Enforcement

    Recall Number
    Z-1664-2014
    Event ID
    68281
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver-Visitec International Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2014
    Initiation Date
    May 6, 2014
    Classification Date
    May 27, 2014
    Termination Date
    September 5, 2014
    Address
    411 Waverley Oaks Rd Ste 229, Waltham, MA, 02452-8422, United States

    Description

    Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth

    Reason

    Contains a sharp tip needle when the product should contain a blunt tip cannula

    Code Info

    Lot number: 3079324

    Distribution

    Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.

    Quantity

    9970 units