BEUDAMED
    FDA Enforcement Class II Ongoing

    VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes

    Recall: Z-0780-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0780-2023
    Event ID
    91315
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2023
    Initiation Date
    December 12, 2022
    Classification Date
    January 3, 2023
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes

    Reason

    Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.

    Code Info

    UDI: 10724995023840 lot #230613

    Distribution

    Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA

    Quantity

    60 boxes