Z-0616-2011

Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC...

Name: Z-0616-2011 Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC...
Creator: Fresenius Kabi, LLC
Published: 2010-10-18
License: https://open.fda.gov/license/

Fresenius Kabi AB / initiated 2010-10-18 / Terminated / root cause: design

FDA source

Fresenius Kabi, LLC began a recall of Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands"... on 2010-10-18. The reason FDA records is "Potential for patient hematocrit dropped to levels lower than expected post-treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0616-2011
Status: Terminated
Initiated: 2010-10-18
Posted: 2010-12-16
Terminated: 2011-10-05
Recalling firm: Fresenius Kabi AB
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.
Product code: LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Reason for recall: Potential for patient hematocrit dropped to levels lower than expected post-treatment.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.

Product code LKN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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)