BEUDAMED
    FDA Enforcement Class II Terminated

    Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.

    Recall: Z-1180-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1180-2016
    Event ID
    73009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    December 4, 2015
    Classification Date
    March 16, 2016
    Termination Date
    August 26, 2016
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.

    Reason

    The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.

    Code Info

    All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.

    Distribution

    Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.

    Quantity

    809 units