BEUDAMED
    FDA Enforcement Class II Terminated

    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

    Recall: Z-1563-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1563-2016
    Event ID
    73117
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    January 22, 2016
    Classification Date
    April 24, 2016
    Termination Date
    August 25, 2016
    Address
    3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, 55144-0001, United States

    Description

    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

    Reason

    3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.

    Code Info

    Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147

    Distribution

    AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.

    Quantity

    74 valves