The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg G

FDA device recall Z-0342-2011 · posted 2010-11-10 · Terminated

Recall details

Recalling firm

Fresenius Kabi, LLC

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CAC

Quantity affected

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, Swit

Date initiated

2010-03-29

Date posted

2010-11-10

Date terminated

2011-06-15

Location

Redmond, WA

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