BEUDAMED
    FDA Enforcement Class II Terminated

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    Recall: Z-0138-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0138-2017
    Event ID
    74542
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    June 23, 2016
    Classification Date
    October 19, 2016
    Termination Date
    January 26, 2017
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    Reason

    New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.

    Code Info

    Model: OER-Pro, All serial numbers affected

    Distribution

    Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY

    Quantity

    2, 686 units