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