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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)

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  Class 2 Device Recall Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA) see related information
Date Initiated by Firm April 19, 2011
Date Posted May 16, 2011
Recall Status1 Terminated 3 on December 06, 2011
Recall Number Z-2199-2011
Recall Event ID 58596
510(K)Number K961706  
Product Classification Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
Product The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031.

Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
Code Information The manual contains the operating instructions for AS 104 Blood Cell Separator and has a Software Version 4.71.   The AS104 Blood Cell Separator Device has a Catalog Number 9007031. 
Recalling Firm/
Fresenius Kabi, LLC
8635 154th Ave NE
Redmond WA 98052-3564
For Additional Information Contact
Manufacturer Reason
for Recall
Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.
FDA Determined
Cause 2
Action Fresenius Kabi sent a "Urgent Notification" letter dated May 6, 2011, to the affected consignees they are recalling the Operating Manual for the Fresinius AS104-Blood Cell Separator. The Red Blood Cell (RBC) sets have been recalled according to recall number Z-0616-2011, and will permanently not be used with the AS 104 Blood Cell Separator Device. The RBC set was never approved by the FDA according to Warning Letter (Reference # GEN1001508) dated 31 January 2011. The customers are being instructed to complete the self addressed postage pre-paid " Product Response Card." Place a check mark next to the disposition choice used. Fresenius plans to send the revised Operating Manual and a notification letters to consignees at the end of April 2011. Consignees who have questions about this recall can call the firm at 1-425-242-2074.
Quantity in Commerce 158 units
Distribution Nationwided Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, NC, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VT, and WI.
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 = LKN and Original Applicant = FRESENIUS USA, INC.