Events

Recall of Fresenius

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Holdings, 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
    71093
  • Event Risk Class
    Class 2
  • Event Number
    Z-1716-2015
  • Event Initiated Date
    2015-04-27
  • Event Date Posted
    2015-06-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136070
  • 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
    Accessories, blood circuit, hemodialysis - Product Code KOC
  • Reason
    Blood chamber connection leaks during the use of the crit-line¿ blood chamber.
  • Action
    Fresenius LLC North America notified accounts by letter sent certified mail on May 22, 2015, expanding the recall to All lots. Previously recall letters were on April 30, 2015, 2nd notice on May 14, 2015. Users are requested to examine inventory, discontinue use and return product. Contact FMCRTG, LLC Customer Service Team 1-800-323-5188 for instructions. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Confirmation of delivery will be obtained through the use of registered mail.

Device

Fresenius
  • Model / Serial
    All lot numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
  • Product Description
    CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters || Model: CL10021021
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Manufacturer Address
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA