Device Recall ATF 40 (item 9108491)

  • Modelo / Serial
    Lot numbers:  YHT242, YIT012, YIT291, YKT011, YKT142, YKT283, YLT302, ZAT262, ZBT125, ZCT 032, and ZCT 295.
  • Clasificación del producto
  • 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: "ATF 40 Fast Start Kit 9108491...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 ATF 40 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. || ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a ¿ inch. suction port and is connected to a vacuum source. || ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. || ATF 40 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
  • 1 Event

Fabricante

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