Events

Recall of Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)

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
    58596
  • Event Risk Class
    Class 2
  • Event Number
    Z-2199-2011
  • Event Initiated Date
    2011-04-19
  • Event Date Posted
    2011-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99655
  • 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
    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.
  • 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.

Device

Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • 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