BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1801-2018 · Initiated February 26, 2018

    Recall

    Recall Number
    Z-1801-2018
    Event Number
    79915
    Firm
    Beaver-Visitec International Inc.
    FEI Number
    1211998
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 26, 2018
    Terminated
    October 30, 2019
    Address
    500 Totten Pond Rd, Waltham, MA, 02451-1916

    Description

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

    Reason

    Products were packaged with incorrect labeling,

    Action

    On 2/26/18 Beaver-Visitec emailed product recall notices to affected customers. Customers were instructed to destroy the affected product, provide objective evidence of the product destruction, then complete and return the customer response form. Customers with questions regarding this recall may contact Customer Service at (866)906-8080.

    Distribution

    US Nationwide and Canada

    Quantity

    1025