BEUDAMED
    FDA Recall Terminated

    Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

    Recall: Z-0458-2021 · Initiated October 7, 2020

    Recall

    Recall Number
    Z-0458-2021
    Event Number
    86596
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FEB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 7, 2020
    Terminated
    July 14, 2021
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

    Reason

    Potential for cleaning solution intrusion into endoscope

    Action

    Steris issued Urgent Medical Device Recall issued letter on 10/7/20 stating reason for recall, health risk and action to take: Please immediately inspect your facility for affected Leak Test Adapters that connect to Olympus endoscopes. The affected Leak Test Adapters have a white plastic valve connector. If you have this Leak Test Adapter, please disconnect from your Acu-sInQ Complete, destroy, and replace with the new Leak Test Adapter included with this Customer Notification Letter. 2. Please complete the Medical Device Recall Response Form included with this Customer Notification Letter. Your STERIS Sales Representative can assist you should you have any questions while completing the form, or when replacing the Leak Test Adapter. 3. Return the completed Medical Device Recall Response Form to STERIS via one of the following three methods: a. Visit https://www.steris.com/medical-device-recall-response-form and complete the form electronically; b. Scan and email the completed form to [email protected]; or c. Fax the completed form to (440) 392-8963. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Katilin Hawranko, Product Manager at (440) 392-7431, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.

    Distribution

    Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates

    Quantity

    293 units:248 units (USA); 45 units OUS