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U.S. Department of Health and Human Services

Class 1 Device Recall Fresenius Red Blood Cell Set (RBC)

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  Class 1 Device Recall Fresenius Red Blood Cell Set (RBC) see related information
Date Initiated by Firm October 18, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on October 05, 2011
Recall Number Z-0616-2011
Recall Event ID 57290
Product Classification Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
Product Fresenius Red Blood Cell Set, Catalog Number 9007601.

The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands".

Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
Code Information Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.
Recalling Firm/
Manufacturer		 Fresenius Kabi, LLC
8635 154th Ave NE
Redmond WA 98052-3564
For Additional Information Contact
800-909-3872
Manufacturer Reason
for Recall		 Potential for patient hematocrit dropped to levels lower than expected post-treatment.
FDA Determined
Cause 2		 Device Design
Action On October 21, 2010, Fresenius Kabi, LLC in Redmond, WA sent a "Field Safety Corrective Action" Letter dated October 18, 2010 to their US Consignees/Customers. On October 22, 2010, the firm followed up with their customers by telephone call. The letter informed the consignees/customers that the Red Blood Cell (RBC) exchange sets for use on the AS104 Blood Cell Separation Device are being recalled. The consignees/customers were advised to examine their stock and determine if they have any affected products on hand. They were instructed to discontinue distributing, using, dispensing the affected products, and return the product to Fresenius Kabi, LLC, 8635 154th Avenue, NE, Redmond, WA 98052. The consignees/customers were also instructed to notify their sub-account customers if the products were further distributed and to complete the Product Recall Response Form and fax it back to 425-242-2101. T If you have any further questions concerning the recall, please contact the Quality Assurance Manager at 800-909-3872.
Quantity in Commerce 255 units.
Distribution Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.
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.
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