DIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise
Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a sterility assurance issue in a critical medical product (peritoneal dialysis solution). Potential leaks from the Luer component could compromise product sterility and allow contamination, creating serious risk for dialysis patients, meeting the rubric criterion for risk-of-harm products at severity 3 (High).
Plain-English summary
Baxter Healthcare Corporation is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution distributed nationwide in the United States. The recall affects specific lots of the solution in AMBU-FLEX II container bags in 2000 mL, 5000 mL, and 6000 mL sizes.
The FDA has classified this as a Class II recall due to a lack of assurance of sterility caused by potential leaks from the Luer component. These leaks could compromise the sterility of the dialysis solution and allow external contamination.
The affected product should not be used. Patients and healthcare providers should identify affected lots using the detailed recall information from the FDA and contact the manufacturer or their healthcare provider regarding replacement product and next steps.
The recalled product
- Product
- DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
- Brand
- DIANEAL LOW CALCIUM WITH DEXTROSE
- Manufacturer
- Baxter Healthcare Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- a) Lots Y403948
- Exp 30-Sep-2024
- Lot Y406277
- Exp 31-Oct-2024. b) Lot 408790
- Exp 30-Nov-2024 and c) Lots Y403740
- Y403740A
- Lots Y405638
- Y405805
- Y407304
- Y407304A Exp 31-Oct-2024
- Lots Y407717
- Y407717A
- Y408554
- Exp 30-Nov-2024
- Lot Y420075
- Exp 30-Apr-2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · DIANEAL LOW CALCIUM WITH DEXTROSE
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Similar recalls
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