BEUDAMED
    FDA Recall Terminated

    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

    Recall: Z-1079-2013 · Initiated November 29, 2012

    Recall

    Recall Number
    Z-1079-2013
    Event Number
    64418
    Firm
    Thermo Fisher Scientific (Asheville) LLC
    FEI Number
    1523845
    Product Code
    JTQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 29, 2012
    Posted
    April 10, 2013
    Terminated
    April 14, 2015
    Address
    401 Mill Creek Rd, Marietta, OH, 45750-4304

    Description

    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

    Reason

    Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.

    Action

    Thermo Fisher sent an Urgent Field Correction Notice letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate all affected products and determine if it is within the recall. If so, they are to return the Acknowledgement Form in order to get replacement hinges and instructions. Upon receipt of the new hinges they are to replace them according to the instructions.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.

    Quantity

    15,567 incubators