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Class 2 Device Recall Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA) |
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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
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Product Classification |
Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
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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.
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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/ Manufacturer |
Fresenius Kabi, LLC 8635 154th Ave NE Redmond WA 98052-3564
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For Additional Information Contact |
425-242-2074
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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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LKN and Original Applicant = FRESENIUS USA, INC.
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