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

OTTAWA, ON, June 15, 2024 /CNW/ -

Summary

Baxter Connector (CNW Group/Health Canada (HC))

• Products: 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.

      Également disponible en français

SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]