BEUDAMED
    FDA Recall Open, Classified

    Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

    Recall: Z-0159-2020 · Initiated September 12, 2019

    Recall

    Recall Number
    Z-0159-2020
    Event Number
    83826
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    HHI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 12, 2019
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

    Reason

    Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

    Action

    Olympus issued notification letter on 9/12/19 via Federal Express two day delivery stating reason for recall, health risk and action to take: 1. Immediately assess any affected product you have in stock, remove it from your inventory and quarantine it until it is shipped back to us. 2.Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization in order to return any affected product at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product.. 4.Fax the completed Reply form to Olympus Market Quality at 484-896-7128 regardless of whether you have any affected inventory at your facility. Contact 484-896-5688 or at [email protected] for any additional information concerning this matter.

    Distribution

    US Nationwide distribution.

    Quantity

    1106 boxes (10 filters/box)