BEUDAMED
    FDA Recall Terminated

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    Recall: Z-2700-2020 · Initiated June 26, 2020

    Recall

    Recall Number
    Z-2700-2020
    Event Number
    85871
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FLG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 26, 2020
    Terminated
    December 22, 2020
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    Reason

    A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.

    Action

    On 6/26/2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that a Steris service technician will contact customer facilities within 45 days to inspect their units and reperform the installation/start-up checklist. Users can continue to use their irrigator(s) prior to this inspection. Users were instructed to continue to visually inspect all instruments for visible debris prior to final high-level disinfection or sterilization, and reprocess if needed. In addition, users should continue to clean and maintain the unit before each cycle. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates.

    Quantity

    1283