Events

Recall of Device Recall Fresenius FDS08 Dialysate Delivery Machine

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
    54546
  • Event Risk Class
    Class 2
  • Event Number
    Z-2227-2010
  • Event Initiated Date
    2009-11-20
  • Event Date Posted
    2010-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88701
  • 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
    System, Dialysate Delivery, Single Patient - Product Code FKP
  • Reason
    Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
  • Action
    An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.

Device

Device Recall Fresenius FDS08 Dialysate Delivery Machine
  • Model / Serial
    Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed to 5404 customers throughout the US and the world.
  • Product Description
    Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
  • Manufacturer
    Fresenius Medical Care North America

Manufacturer

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