The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71
FDA device recall Z-2199-2011 · posted 2011-05-16 · Terminated
Recall details
- Recalling firm
- Fresenius Kabi, LLC
- 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.
- Action taken
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- LKN
- Quantity affected
- 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.
- Date initiated
- 2011-04-19
- Date posted
- 2011-05-16
- Date terminated
- 2011-12-06
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR (K961706) | Fresenius USA, Inc. | 1996-07-31 |