Events

Retiro De Equipo (Recall) de Fresenius Red Blood Cell Set (RBC)

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
    57290
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0616-2011
  • Fecha de inicio del evento
    2010-10-18
  • Fecha de publicación del evento
    2010-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95762
  • 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
    Potential for patient hematocrit dropped to levels lower than expected post-treatment.
  • Acción
    On October 21, 2010, Fresenius Kabi, LLC in Redmond, WA sent a "Field Safety Corrective Action" Letter dated October 18, 2010 to their US Consignees/Customers. On October 22, 2010, the firm followed up with their customers by telephone call. The letter informed the consignees/customers that the Red Blood Cell (RBC) exchange sets for use on the AS104 Blood Cell Separation Device are being recalled. The consignees/customers were advised to examine their stock and determine if they have any affected products on hand. They were instructed to discontinue distributing, using, dispensing the affected products, and return the product to Fresenius Kabi, LLC, 8635 154th Avenue, NE, Redmond, WA 98052. The consignees/customers were also instructed to notify their sub-account customers if the products were further distributed and to complete the Product Recall Response Form and fax it back to 425-242-2101. T If you have any further questions concerning the recall, please contact the Quality Assurance Manager at 800-909-3872.

Device

Fresenius Red Blood Cell Set (RBC)
  • Modelo / Serial
    Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.
  • Descripción del producto
    Fresenius Red Blood Cell Set, Catalog Number 9007601. || The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". || Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 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