Fresenius Kabi, LLC: 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.

Recall number

Z-0342-2011

Recalling firm

Fresenius Kabi, LLC

Product

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.

Status

Terminated

Initiated

2010-03-29

Posted

2010-11-10

Terminated

2011-06-15

Reason

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.

Root cause

Other

Action

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.

Quantity

25, 740 units distributed in US.

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.

Lot, serial or model codes

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.

510(k) numbers

["K960006"]

PMA numbers

not on file

Product code

CAC

Firm FEI

3007344667

Firm city

Redmond

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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