Baxter recalls two lots of Extraneal peritoneal dialysis solution because of high levels of sodium hypochlorite, which may pose serious health risks

March 23, 2019
For immediate release

OTTAWA – Health Canada is advising Canadians that Baxter Corporation is voluntarily recalling two lots of Extraneal peritoneal dialysis solution as a precautionary measure because of high levels of sodium hypochlorite.

Use of the affected product in patients could cause chemical peritonitis. Chemical peritonitis is inflammation of the peritoneum (the lining of the abdomen and pelvis), which can be serious if not promptly treated. Symptoms include nausea, vomiting, and abdominal pain or tenderness. The high levels of sodium hypochlorite are found in the active pharmaceutical ingredient icodextrin, and can cause discolouration of the solution.

Extraneal is a sterile peritoneal dialysis solution used for patients whose kidneys are not working properly. The dialysis solution is used in hospitals and home settings. The lots affected by this recall were distributed by Baxter between March 14, 2019 and March 20, 2019.

Affected products
Product DIN Product Code Lot Expiry
Extraneal 2L/2L Twinbag 02240806 JB9912 W9B28T0 02/29/2020
Extraneal 7.5% 2.5L SYSII 02240806 JB9923LP W9C05T1 03/31/2020

What you should do

  • Immediately examine your stock to determine whether you have product from the affected lot. The product code and lot number can be found on the individual product or shipping carton.
  • If you have affected product, speak to your healthcare provider immediately regarding replacement product.
  • Contact Baxter Corporation Customer Care at 1-866-968-7477 for instructions on how to return the recalled product.
  • Talk to your doctor or nurse if you have used product from the affected lot.
  • Report any health product-related adverse reactions or complaints to Health Canada.

Who is affected

Canadians who have product from the affected lots.

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

Public Enquiries:

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

What Health Canada is doing

Health Canada is monitoring the recall. Should Health Canada become aware of additional safety information, it will take appropriate action and inform Canadians as necessary.

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