Fresenius Kabi, LLC

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.

Anesthesiology Devices

2

No

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.

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.

Lot numbers:  YHT242, YIT012, YIT291, YKT011, YKT142, YKT283, YLT302, ZAT262, ZBT125, ZCT 032, and ZCT 295.

Anesthesiology Devices

2

No

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.

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.

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.

Anesthesiology Devices

2

No

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.

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.