Public recall detail

Dianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose peritoneal dialysis solutions recalled due to risk of leakage at connection site

2024-06-14

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Recall Safety notice
Quick summary

Quick summary: Dianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose peritoneal dialysis solutions recalled due to risk of leakage at connection site. Date: 2024-06-14.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Dianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose peritoneal dialysis solutions recalled due to risk of leakage at connection site. Date: 2024-06-14.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandVantive ULC, Physioneal, Dianeal
ProductDianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose peritoneal dialysis solutions
IssueHealth products - Product quality
Recall classType I
IdentificationRA-75668

Affected products

BrandPhysioneal
ProductPhysioneal 40 2.27% Glucose 2500ml
DIN / NPN / authorizationDIN 02247722
Dosage formSolution
StrengthCALCIUM 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
LotW4B26T2
BrandDianeal
ProductDianeal PD4 2.5% 3L/3L and SY2
DIN / NPN / authorizationDIN 00865109
Dosage formSolution
StrengthCALCIUM 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
LotW4C09T0, 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 official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesVantive ULC (wholly-owned subsidiary of Baxter International Inc.) 6675 Millcreek Drive, Unit 2, Mississauga, ON L9R 1J4
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75668
Background{}
CompaniesVantive ULC (wholly-owned subsidiary of Baxter International Inc.) 6675 Millcreek Drive, Unit 2, Mississauga, ON L9R 1J4
AudiencesGeneral public Healthcare Industry
Source updated2024-06-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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