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Important Safety Information on Recall of Additional Lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate due to Potential Bacterial Contamination

Starting date:
July 17, 2015
Posting date:
July 20, 2015
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-54288

Audience

Hospitals, Haemodialysis Clinics, Home Haemodialysis Programs and Patients who may have received this product. Please distribute to Healthcare Professionals who may administer the product to patients and post this notice in all relevant areas in your institution.

Key messages

  • Specific lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate in 6.4 L volumes that may contain higher bacterial levels than acceptable are being recalled by Fresenius Medical Care, in consultation with Health Canada.
  • This recall is in addition to lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate, 6.4 L Bottles and 8 L Bottles that were previously recalled on May 14, 2015.
  • Bacterial contamination poses a potential risk of bacteremia (bacteria in the bloodstream) from the contamination of dialysis concentrates.
  • Do not use product from the affected lots (see “Products Affected” section below). 

Issue

Further to the voluntary recall conducted by Fresenius Medical Care on May 14, 2015, additional lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate in 6.4L volumes are being recalled due to possible bacterial contamination. Alternative Sodium Bicarbonate Liquid Concentrate has been sourced by Fresenius from other vendors and is available to replace your existing inventory and ensure an uninterrupted supply for your clinic and patients.

This product is used in haemodialysis, which removes waste products from the blood by passing the blood out of the body through a filtering system and returning the cleaned blood to the body when the kidneys are not functioning properly.

The affected product subject to the current recall was distributed to hospitals and home settings between February 23, 2015 and July 15, 2015.  Users should check lots (see “Products Affected” section below) prior to administering or using this product.

Products affected 

NaturaLyte® Sodium Bicarbonate Liquid Concentrate (DIN:02230083) in 6.4L volume with lots that begin with:  15AMLBxxx, 15BMLBxxx, and 15CMLBxxx.

NaturaLyte® Sodium Bicarbonate Liquid Concentrate (DIN:02230083) in 6.4L and 8L volumes with lots that begin with:  14DMLBxxx, 14EMLBxxx, 14HMLBxxx, 14JMLBxxx, 14KMLBxxx, 14LMLBxxx, 14NMLBxxx, 14PMLBxxx, and 14SMLBxxx were previously recalled on May 14, 2015.

Background information

One lot of NaturaLyte® Sodium Bicarbonate Liquid Concentrate manufactured in 2014 showed elevated bacterial contamination results during ongoing stability shelf life testing.  Three different lots were destroyed and never distributed on the market when they exceeded the acceptable level for bacterial contamination. Subsequently, testing of lots manufactured in 2015 indicated that one bottle exceeded the acceptable specification for product release. The affected lot was not distributed in Canada, however the possibility that other lots manufactured in 2014 and 2015 might also show growth could not be excluded.

The risk of bacteremia is directly related to patient bacterial exposure. Several measures, including the use of the DIASAFEplus® filter or equivalent, and the use of a dialyzer, significantly reduce the risk but do not completely eliminate it.

Who is affected

Information for consumers

  • Do not use the affected lots.
  • Dialysis schedules should not be interrupted without appropriate assessment and direction by the prescriber. If alternatives are not immediately available, then contact and follow the advice of your healthcare professional regarding your dialysis treatment.
  • If affected product was used previously on the dialysis machine, the dialysis system should be disinfected (including heat) before beginning treatment using unaffected product.
  • Report any adverse events to Health Canada.

Information for health care professionals

  • Immediately examine your stock to determine whether you have any of the affected product lots, discontinue use of affected product and place these units in a segregated, secure area.
  • Contact any home haemodialysis patients who may have received affected product to inform them of the recall, not to use product from the affected lots and ensure that they have alternative product.
  • If affected product was used previously on the dialysis machine, the dialysis system should be disinfected (including heat) prior to initiation of patient treatment with unaffected product.
  • Product from affected lots should be returned as outlined in the Recall Notice issued by Fresenius Medical Care Canada on July 20, 2015.

If you have any additional concerns or questions, please contact the quality department at: 1-888-709-4411 or email: julie.kubien@fmc-na.com.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and to the public through its MedEffect Canada website. Health Canada is also monitoring the situation and the implementation of necessary corrective and preventative actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious bacteremia, infection or unexpected side effects in patients receiving NaturaLyte® Sodium Bicarbonate Liquid Concentrate should be reported to Fresenius Medical Care Canada or Health Canada.

Fresenius Medical Care Canada, Inc.
45 Staples Ave. Suite 110,
Richmond Hill Ontario L4B 4W6
Telephone: 1-888-709-4411
Email: julie.kubien@fmc-na.com

To correct your email address or recall contact, contact Fresenius Medical Care Canada Inc.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax

For other health product inquiries related to this communication, contact Health Canada at:

Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636


For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.