BEUDAMED
    FDA Recall Terminated

    3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.

    Recall: Z-1318-2014 · Initiated March 17, 2014

    Recall

    Recall Number
    Z-1318-2014
    Event Number
    67716
    Firm
    3M Company Health Care Business 3M Center
    FEI Number
    2110898
    Product Code
    FLF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 17, 2014
    Posted
    April 2, 2014
    Terminated
    January 22, 2015
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144

    Description

    3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.

    Reason

    Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20

    Action

    3M sent an "Urgent Medical Device Field Correction" letter dated March 6, 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are being notified because our records indicate you received a unit that contains the cartridge puncture assembly that is the subject of this field correction. 3M will contact you to schedule an appointment for a field correction on any unit in the range of serial numbers provided in the table. 3M's goal is to service the affected units with minimal disruption to your facility. Units manufactured outside of the dates November 10, 2006 to December 14, 2007 are not affected. .For Further Information contact 3M Health Care Service Line at 1-800-228-3957 or your local 3M representative.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including the states of AL, AZ, CA,CO, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, NE, NJ, NY, NC, ND, OH, OK,OA, SC, TX, WA, WV and WI. and the countries of COLOMBIA, VENEZUELA, UAE, THAILAND, GERMANY, CHINA, KOREA, CANADA, JAPAN, RUSSIA, INDIA, POLAND, PERU, AUSTRIA, ISRAEL, INDONESIA, SPAIN, CHILE, MALAYSIA, SWITZERLAND, EL SALVADOR, ECUADOR, LEBANON, MEXICO, ARGENTINA, BULGARIA, TAIWAN, TURKEY,ROMANIA, GUATEMALA and NEW ZEALAND.

    Quantity

    73 US, 346 OUS