Events

Recall of Device Recall Naturalyte Liquid Bicarbonate Concentrate

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
    71724
  • Event Risk Class
    Class 2
  • Event Number
    Z-2373-2015
  • Event Initiated Date
    2015-07-16
  • Event Date Posted
    2015-08-12
  • 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=138829
  • 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
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • Reason
    Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
  • Action
    Fresenius Medical NA issued an Urgent Expanded Medical Device Recall letter on 7/16/15 to clinics and patients. The letter identified the affected product, explained the reason for the expansion, and instructed users to immediately examine their stock to determine whether there was any Naturalyte Liquid Bicarbonate Concentrate beginning with 15AMLB, 15BMLB, 15CMLB. Users are to discontinue use immediately if any product of these lots is found, . All units are to be placed in a secure, segregated area. If affected product was on the machine prior to patient treatment, a [Heat Disinfect] program should be performed. The attached Reply Form should be completed and returned. Contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.

Device

Device Recall Naturalyte Liquid Bicarbonate Concentrate
  • Model / Serial
    Lots begin with: 15AMLB, 15BMLB, 15CMLB.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle || A Dialysate Concentrate for Hemodialysis (liquid) || Product Code: 08-4000-LB
  • 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