BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1563-2016 · Initiated January 22, 2016

    Recall

    Recall Number
    Z-1563-2016
    Event Number
    73117
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    FLF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 22, 2016
    Terminated
    August 25, 2016
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001

    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.

    Action

    3M sent an Urgent Medical Device Field Correction letter to customers beginning 01/22/2016. The letter identified affected product, and stated that a 3M Service representative will contact the consignee to inspect the sterilizer. Questions can be directed to 3M Health Care Service Line at 1-800-228-3957.

    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