Class 2 Device Recall ATF 40 (item 9108491)

• Date Initiated by Firm: March 29, 2010
• Date Posted: November 10, 2010
• Recall Status: Terminated on June 15, 2011
• Recall Number: Z-0341-2011
• Recall Event ID: 56751
• 510(K)Number: K960006
• Product Classification: Apparatus, autotransfusion - Product Code CAC
• Product: 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.
• Code Information: Lot numbers: YHT242, YIT012, YIT291, YKT011, YKT142, YKT283, YLT302, ZAT262, ZBT125, ZCT 032, and ZCT 295.
• Recalling Firm/ Manufacturer: Fresenius Kabi, LLC; 14715 Ne 95th St Ste 100; Redmond WA 98052-2566
• For Additional Information Contact: Kathryn Sivertson; 425-242-2000
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 17, 444 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAC