BEUDAMED
    FDA Enforcement Class II Terminated

    bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    Recall: Z-0500-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0500-2018
    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 EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 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    The protective shield was retracted, and the blade was exposed.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

    (a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976 (b) REF 378233; Batch numbers: 3191985 3204382 3225442

    Distribution

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

    Quantity

    45, 680 units