Device Recall ATF 120 (item 9108501)

  • Modèle / numéro de série
    Lot numbers:  YHT 103, YHT 124, YHT 262, YIT 042, YIT 112, YIT 181, YKT 061, YKT 083, YKT 212, YKT 291, YLT 053, YLT 101, YLT 182, YMT 092, YMT 172, ZAT 292, ZBT 192, ZBT 262, ZCT 121, and ZCT 311.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    The box label states: "ATF 120 Fast Start Kit 9108501...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 ATF120 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR120 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 1/4 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 120 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

Fabricant

  • Adresse du fabricant
    Fresenius Kabi, LLC, 14715 Ne 95th St Ste 100, Redmond WA 98052-2566
  • Société-mère du fabricant (2017)
  • Source
    USFDA