Events

Recall of Device Recall Fresenius Bicarbonate Jug Adapter

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
    66953
  • Event Risk Class
    Class 2
  • Event Number
    Z-0920-2014
  • Event Initiated Date
    2013-12-17
  • Event Date Posted
    2014-02-03
  • 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=124291
  • 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
    Bicarbonate jug adapter distributed prior to 510(k) approval.
  • Action
    Fresenius notified customers by telephone and Formal notification on 12/17/13 via the Urgent Bicarbonate Jug Adapter Recall letter sent certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they are instructed to discontinue use and place all Bicarbonate Jug Adapters in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product.

Device

Device Recall Fresenius Bicarbonate Jug Adapter
  • Model / Serial
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine || Part Number: 650103. || The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
  • 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