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U.S. Department of Health and Human Services

Class 2 Device Recall AT1 Autotransfusion Set (item 9005101)

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 Class 2 Recall
AT1 Autotransfusion Set (item 9005101)
see related information
Date Posted November 10, 2010
Recall Status1 Terminated on June 15, 2011
Recall Number Z-0340-2011
Recall Event ID 56751
Premarket Notification
510(K) Number
K960006 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Fresenius Kabi, LLC
14715 Ne 95th St Ste 100
Redmond, Washington 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 2
OTHER/UNDETERMINED: Pending
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 18, 200 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = FRESENIUS AG
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