BEUDAMED
    FDA Recall Terminated

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    Recall: Z-0501-2018 · Initiated November 3, 2017

    Recall

    Recall Number
    Z-0501-2018
    Event Number
    78789
    Firm
    Beaver-Visitec International Inc.
    FEI Number
    1211998
    Product Code
    EMF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 3, 2017
    Posted
    February 1, 2018
    Terminated
    May 31, 2023
    Address
    411 Waverley Oaks Rd, Ste 229, Waltham, MA, 02452-8422

    Description

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 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    The protective shield was retracted, and the blade was exposed.

    Action

    The firm disseminated their safety advisory notices on 11/03/2017 by email and visit. The letter identified the affected product, problem and actions to be taken. The firm requested the following action:"Prior to opening the Tyvek tray, please visually confirm that the plastic shield is not retracted and the activation slider is fully engaged."

    Distribution

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

    Quantity

    572,490 units