Events

Retiro De Equipo (Recall) de Device Recall AT1 Autotransfusion Set (item 9005101)

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
    56751
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0340-2011
  • Fecha de inicio del evento
    2010-03-29
  • Fecha de publicación del evento
    2010-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94446
  • 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
    Apparatus, autotransfusion - Product Code CAC
  • Causa
    Using at1 autotransfusion set from specific batches in combination with the auto transfusion device cats continuous autotransfusion has led to insufficient suction of shed blood from the collection reservoir. the results in the failure message "alarm blood flow" and the cats device stops in a secure mode.
  • Acción
    Fresenius Kabi sent out a Technical Notification letter dated March 29, 2010, to one distributor located in Ann Arbor, Michigan. The distributor sent the technical notification with a cover letter to each of their customer's that had ordered AT1's, ATF120's and ATF40's over the last year. The letter identified the product, the problem, and the action to be taken. Customers were notified that the autotransfusion prime and / or washing procedure can be continued after alarm blood flow by following Alternative procedures. The Technical Notification informs the distributor about the problem of the AT1 (item #9005101), but also mentions the other two products ATF120 (item #9108501) and ATF40 (item #9108491) which have no known problem. The distributor is advised to contact Fresenius Kabi, LLC for any question regarding the Technical Notification. For questions regarding this recall call (425) 242-2074.

Device

Device Recall AT1 Autotransfusion Set (item 9005101)
  • Modelo / Serial
    Lot numbers:  YFT 223, YFT 242, YFT 261, YHT 271, YHT 283, YIT 021, YIT 072, YIT 083, YIT 161, YIT 172, YIT 211, YKT 161, YKT 263, YLT 023, YLT 042, YLT 062, YLT 121, YLT 172, YLT 231, YLT 262, YLT 271, and YMT 011.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA and the countries of Australia,Austria, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, Phillipines, Portugal, Switzerland, Thailand, UK, and Vietnam.
  • Descripción del producto
    The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". || The AT1 Autotransfusion Set is distributed by Fresenius Kabi on its own or as part of a ATF40 kit or ATF120 kit. || AT1 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
  • Manufacturer
    Fresenius Kabi, LLC

Manufacturer

Fresenius Kabi, LLC
  • Dirección del fabricante
    Fresenius Kabi, LLC, 14715 Ne 95th St Ste 100, Redmond WA 98052-2566
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA