Dianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose peritoneal dialysis solutions recalled due to risk of leakage at connection site
Brand(s)
Summary
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
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
Physioneal |
Physioneal 40 2.27% Glucose 2500ml |
DIN 02247722 |
Solution |
CALCIUM CHLORIDE 0.507 G / L, DEXTROSE 62.6 G / L, MAGNESIUM CHLORIDE 0.14 G / L, SODIUM BICARBONATE 3.29 G / L, SODIUM CHLORIDE, 8.43 G / L, SODIUM LACTATE 2.63 G / L |
W4B26T2 |
Dianeal |
Dianeal PD4 2.5% 3L/3L and SY2 |
DIN 00865109 |
Solution |
CALCIUM CHLORIDE 18.3 MG / 100 ML, DEXTROSE 2.5 G / 100 ML, MAGNESIUM CHLORIDE 5.08 MG / 100 ML, SODIUM CHLORIDE 538 MG / 100 ML, SODIUM LACTATE 448 MG / 100 ML |
W4C09T0, W4B26T4, W4B29T1, W4C07T1, W4C18T2 |
Issue
Product sterility may be compromised in affected lots.
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
Background
Depth of recall: Wholesalers, Healthcare Establishments, Home Patients
Details
Vantive ULC (wholly-owned subsidiary of Baxter International Inc.)
6675 Millcreek Drive, Unit 2,
Mississauga, ON
L9R 1J4
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