Z-2199-2011

The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software...

Name: Z-2199-2011 The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software...
Creator: Fresenius Kabi, LLC
Published: 2011-04-19
License: https://open.fda.gov/license/

Fresenius Kabi AB / initiated 2011-04-19 / Terminated

FDA source

Fresenius Kabi, LLC began a recall of 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... on 2011-04-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2199-2011
Status: Terminated
Initiated: 2011-04-19
Posted: 2011-05-16
Terminated: 2011-12-06
Recalling firm: Fresenius Kabi AB
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.
Product code: LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
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 root cause: PMA
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.
Product codes and lots: 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.

Product code LKN

K961706UnclassifiedP1r Plasma Treatment Set for Use in Plasmapheresis with the Fresenius As104 Cell SeparatorFresenius USA, Inc. / cleared 1996-07-31

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)