Recall Z-0340-2011 ยท CAC Apparatus, Autotransfusion
Fresenius Kabi, LLC
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 Freseni
| Date | Nov 10, 2010 (initiated Mar 29, 2010) |
| Status | Terminated |
| 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 proble |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960006 | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM Fresenius AG, Jul 31, 1996 |