Events

Retiro De Equipo (Recall) de Device Recall BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850

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 Arizant Inc.

¿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
    54487
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0896-2010
  • Fecha de inicio del evento
    2009-12-17
  • Fecha de publicación del evento
    2010-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88576
  • 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
    system, thermal regulating - Product Code DWJ
  • Causa
    Arizant healthcare inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (arizant part number 502221 model 90024) attached to its temperature management units and pressure infusion power pack (bair paws¿ temperature management units: models 850 and 875 bair hugger¿ temperature management units: models 500/or, 505 (human & vet.), 750 (human & vet) and 775 ranger¿ blood/flui.
  • Acción
    An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.

Device

Device Recall BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
  • Modelo / Serial
    Part number 502221 Model 90024
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.
  • Descripción del producto
    Electri-Cord Manufacturing Corporation(312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Pressure Infusion Power Pack; Model 90033. || To provide power to pressure infusers.
  • Manufacturer
    Arizant Inc

Manufacturer

Arizant Inc
  • Dirección del fabricante
    Arizant Inc, 10393 W 70th St, Eden Prairie MN 55344
  • Source
    USFDA