Events

Recall of Device Recall AMICUS Exchange Kit

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

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
    65296
  • Event Risk Class
    Class 2
  • Event Number
    Z-1523-2013
  • Event Initiated Date
    2013-05-24
  • Event Date Posted
    2013-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118494
  • 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
    Fenwal has initiated a voluntary urgent product recall for lot fa12c07070 of product code r4r2339, amicus exchange kits. fenwal identified a labeling issue with this batch of product code r4r2339 (which was cleared for european use only) in which this batch was distributed within the united states market. the problem is identified as labeling that did not include the written description for the s.
  • Action
    Fenwal sent an Urgent Product Recall letter dated May 24, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, discontinue the use of this prod.uct, return the affected product to Fenwal, and complete and return the attached reply form. For questions call 1-800-333-6925.

Device

Device Recall AMICUS Exchange Kit
  • Model / Serial
    Model No.: R4R2339;  Lot No.: FA12C07070;  Expiration Date: 03/2014
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    AMICUS Exchange Kit; || Product Usage: || This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
  • Manufacturer
    Fenwal Inc

Manufacturer

Fenwal Inc
  • Manufacturer Address
    Fenwal Inc, 3 Corporate Dr Ste 300, Lake Zurich IL 60047-8930
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co. KGaA
  • Source
    USFDA