Events

Recall of Device Recall Fresenius Medical Care

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care North America.

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
    34165
  • Event Risk Class
    Class 3
  • Event Number
    Z-0333-06
  • Event Initiated Date
    2005-11-28
  • Event Date Posted
    2005-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43216
  • 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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Reason
    Mislabeled: inner product mislabeled as f180nr (catalog number 0500318n) instead of f160nr.
  • Action
    Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.

Device

Device Recall Fresenius Medical Care

Manufacturer

Fresenius Medical Care North America
  • Manufacturer Address
    Fresenius Medical Care North America, 95 Hayden Avenue, Lexington MA 02421-7942
  • Source
    USFDA