FDA Medical Device Recalls (openFDA)
Fresenius Kabi, LLC: 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.
- Recall number
- Z-0616-2011
- Recalling firm
- Fresenius Kabi, LLC
- 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.
- Status
- Terminated
- Initiated
- 2010-10-18
- Posted
- 2010-12-16
- Terminated
- 2011-10-05
- Reason
- Potential for patient hematocrit dropped to levels lower than expected post-treatment.
- 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
- 255 units.
- Distribution
- Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.
- Lot, serial or model codes
- Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LKN
- Firm FEI
- 3007344667
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28