BEUDAMED
    FDA Enforcement Class II Terminated

    Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549

    Recall: Z-1801-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1801-2018
    Event ID
    79915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver-Visitec International Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 16, 2018
    Initiation Date
    February 26, 2018
    Classification Date
    May 10, 2018
    Termination Date
    October 30, 2019
    Address
    500 Totten Pond Rd, N/A, Waltham, MA, 02451-1916, United States

    Description

    Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549

    Reason

    Products were packaged with incorrect labeling,

    Code Info

    Lot number: 6001035

    Distribution

    US Nationwide and Canada

    Quantity

    1025