Thermo Fisher Scientific (Asheville) LLC recalls CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542,

Recalled April 17, 2013 · FDA recall Z-1079-2013 · Thermo Fisher Scientific (Asheville)

Hazard

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

Units

15,567 incubators

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Thermo Fisher Scientific (Asheville) LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →