Events

Recall of Fresenius Red Blood Cell Set (RBC)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Kabi, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57290
  • Event Risk Class
    Class 1
  • Event Number
    Z-0616-2011
  • Event Initiated Date
    2010-10-18
  • Event Date Posted
    2010-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95762
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
  • Reason
    Potential for patient hematocrit dropped to levels lower than expected post-treatment.
  • 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.

Device

Fresenius Red Blood Cell Set (RBC)
  • Model / Serial
    Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.
  • Product Description
    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.
  • Manufacturer
    Fresenius Kabi, LLC

Manufacturer

Fresenius Kabi, LLC
  • Manufacturer Address
    Fresenius Kabi, LLC, 8635 154th Ave NE, Redmond WA 98052-3564
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA