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/ -
- 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.
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 |
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.
- 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, (613) 957-2983, [email protected]; Public Enquiries: (613) 957-2991, 1-866 225-0709, [email protected]
Share this article