Device Recall AT1 Autotransfusion Set (item 9005101)

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.