Recall Z-2199-2011 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Fresenius Kabi, LLC
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.
| Date | May 16, 2011 (initiated Apr 19, 2011) |
| Status | Terminated |
| Reason | 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. |
| 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 mar |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR Fresenius USA, Inc., Jul 31, 1996 |