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| Canada: Dianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose peritoneal dialysis solutions recalled due to risk of leakage at connection site (English only) |
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Health Canada announces that 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 products are:
- Dianeal PD4 2.5% Dextrose 3,000 mL (lot number: W4C09T0)
- Dianeal PD4 2.5% Dextrose 5,000 mL (lot number: W4B26T4, W4B29T1, W4C07T1, W4C18T2)
- Physioneal 40 2.27% Glucose 2,500 mL (lot number: W4B26T2)
The affected lots were distributed in Canada between March 6, 2024, and May 29, 2024. 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.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/dianeal-pd4-25-dextrose-and-physioneal-40-227-glucose-peritoneal-dialysis-solutions
In Hong Kong, Dianeal Low Calcium Peritoneal Soln 2.5% (HK-35012), Dianeal Low Ca P.D. Soln W/2.5% Dextrose (HK-42531) and Dianeal Low Calcium Peritoneal Dialysis Solution With 2.5% Dextrose (Ultra Bag) (HK-62709) are pharmaceutical products registered by Baxter Healthcare Ltd (Baxter). The products are prescription-only medicines. As confirmed by Baxter, the manufacturer of the products recalled in Canada is different from the Hong Kong registered products, and the affected lots have not been imported into Hong Kong. Related news was previously issued by Health Sciences Authority and Taiwan Food and Drug Administration, and was posted on the Drug Office website on 8 Dec 2020 and 11 Dec 2020.
Ends/Monday, Jun 17, 2024
Issued at HKT 17:00
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