Public advisory

Dianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose peritoneal dialysis solutions recalled due to risk of leakage at connection site

Last updated

Summary

Product
Dianeal PD4 2.5% Dextrose peritoneal dialysis solution (3,000 mL and 5,000 mL); Physioneal 40 2.27% Glucose peritoneal dialysis solution (2,500 mL)
Issue
Health products - Product safety
What to do

Immediately check your stock to see if your product is affected. If you have an affected product, do not use it and immediately speak to your health care provider to obtain a replacement. Consult a health care professional if you have used the affected product and you have health concerns.

Affected products

Product

DIN

Lot

Expiry

Dianeal PD4 2.5% Dextrose 3,000 mL

00865109

W4C09T0

03/31/2026

Dianeal PD4 2.5% Dextrose 5,000 mL

00865109

W4B26T4
W4B29T1
W4C07T1
W4C18T2

02/28/2026
02/28/2026
03/31/2026
03/31/2026

Physioneal 40 2.27% Glucose 2,500 mL

02247722

W4B26T2

02/28/2025

Issue

Vantive ULC (a subsidiary of Baxter Corporation) is recalling certain lots of Dianeal and Physioneal peritoneal dialysis solutions because of possible leakage at the connection site . The affected lots were distributed in Canada between March 6, 2024, and May 29, 2024.

Dianeal and Physioneal are sterile peritoneal dialysis solutions used in hospitals and home settings to treat patients whose kidneys are not working properly.

Products with leakage at the connection site may become contaminated, exposing patients to microbial contamination and an increased risk of peritonitis. Peritonitis is when the thin layer of tissue inside the abdomen, called the peritoneum, becomes inflamed. Symptoms of peritonitis include fever and chills, belly pain or tenderness, feeling bloated, upset stomach and vomiting, loss of appetite, diarrhea or constipation, extreme fatigue and confusion. Peritonitis can result in death.

Health Canada is monitoring the company's recall, and its implementation of any necessary corrective and preventative actions to prevent this issue from reoccurring. The Department will inform the public if any new health risks are identified.

What you should do

  • Immediately check your stock to see if your product is affected. If you have an affected product, do not use it, and immediately speak to your health care provider to obtain a replacement.
  • Consult a health care professional if you have used the affected product and you have health concerns.
  • Contact Baxter Corporation toll-free at 1-888-719-9955 if you have questions about the recall.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
General public
Identification number
RA-75672
Media and public enquiries

Media Enquiries: Également disponible en français

Health Canada

613-957-2983

media@hc-sc.gc.ca

Public Enquiries:

613-957-2991

1-866-225-0709

info@hc-sc.gc.ca

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