Events

Retiro De Equipo (Recall) de Device Recall CO2 Incubators (General Purpose Incubator),

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Thermo Fisher Scientific (Asheville) LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64418
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1079-2013
  • Fecha de inicio del evento
    2012-11-29
  • Fecha de publicación del evento
    2013-04-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116104
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bath, incubators/water, all - Product Code JTQ
  • Causa
    Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
  • Acción
    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.

Device

Device Recall CO2 Incubators (General Purpose Incubator),
  • Modelo / Serial
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
    Thermo Fisher Scientific (Asheville) LLC

Manufacturer

Thermo Fisher Scientific (Asheville) LLC
  • Dirección del fabricante
    Thermo Fisher Scientific (Asheville) LLC, 401 Mill Creek Rd, Marietta OH 45750-4304
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA