Baxter recalls certain lots of hemodialysis solutions due to particulate matter found in the product

Starting date:

September 19, 2014

Posting date:

September 19, 2014

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Contamination

Audience:

General Public

Identification number:

RA-41491

• Issue
• Products affected
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing

Issue

Baxter Corporation, in collaboration with Health Canada, is voluntarily recalling specific lots of two Acid Concentrate hemodialysis solutions (see below) due to particulate matter found in the product. Particulate matter in the product may cause inadequate dialysis and may result in serious injury such as allergic reactions or blockage of small blood vessels if it enters into a patient's bloodstream.

The affected products were distributed to hospital and home settings between January 31, 2014 and July 18, 2014. These products are used in home hemodialysis patients. Those who administer these products in home-care settings should check the lot numbers before administration.

Products affected

1. Acid Concentrate 45X (45 K, 67.5 Ca) (DIN 02158256) Lot No. W4D17D1
2. Acid Concentrate 45X (45 K, 45.0 Ca) (DIN 00860611) Lot No. W4A24D1

What you should do

• Immediately examine your stock to determine whether you have any of the affected product lots. If any of these are found, speak to your healthcare provider immediately regarding replacement product.
• Contact Baxter Corporation Customer Care at 1-888-719-9955 for instructions on how to return the recalled product.
• Report any adverse events to Health Canada.

Who is affected

Canadians who have used the affected lots of either of these two products. The company has indicated that it has not received reports of any adverse events associated with the particulate matter.

Background

These products are used as a form of dialysis (hemodialysis) that removes waste products from the blood by passing them out of the body through a filtering system and returning them, cleaned, to the body.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

Health Canada is monitoring the recall and working with the company to help ensure patients and healthcare professionals are informed. Health Canada will provide an update to Canadians, as necessary.