Events

Retiro De Equipo (Recall) de Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)

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 Fresenius Kabi, 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
    58596
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2199-2011
  • Fecha de inicio del evento
    2011-04-19
  • Fecha de publicación del evento
    2011-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99655
  • 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
    Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
  • Causa
    Operating manual of the as 104 blood cell separator is being updated to eliminate any reference to red blood cell (rbc), c4y, p1y and bmsc sets. this is a corrective action and recall expansion of z-0616-2011.
  • Acción
    Fresenius Kabi sent a "Urgent Notification" letter dated May 6, 2011, to the affected consignees they are recalling the Operating Manual for the Fresinius AS104-Blood Cell Separator. The Red Blood Cell (RBC) sets have been recalled according to recall number Z-0616-2011, and will permanently not be used with the AS 104 Blood Cell Separator Device. The RBC set was never approved by the FDA according to Warning Letter (Reference # GEN1001508) dated 31 January 2011. The customers are being instructed to complete the self addressed postage pre-paid " Product Response Card." Place a check mark next to the disposition choice used. Fresenius plans to send the revised Operating Manual and a notification letters to consignees at the end of April 2011. Consignees who have questions about this recall can call the firm at 1-425-242-2074.

Device

Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)
  • Modelo / Serial
    The manual contains the operating instructions for AS 104 Blood Cell Separator and has a Software Version 4.71.   The AS104 Blood Cell Separator Device has a Catalog Number 9007031.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwided Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, NC, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VT, and WI.
  • Descripción del producto
    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. || Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
  • Manufacturer
    Fresenius Kabi, LLC

Manufacturer

Fresenius Kabi, LLC
  • Dirección del fabricante
    Fresenius Kabi, LLC, 8635 154th Ave NE, Redmond WA 98052-3564
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA