Dianeal Peritoneal Dialysis Solution Recalled for Potential Sterility Compromise
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The recall affects 22,112 bags nationwide.
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: Risk-of-harm product (peritoneal dialysis solution with potential sterility compromise from container leaks). No illnesses or injuries have been reported. Classified as FDA Class II without reported adverse events, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks originating from the Luer component. These leaks could compromise the sterility assurance of the product, which is critical for safe intraperitoneal use.
The recall affects 22,112 bags of the product (Lot Y406734, expiring October 31, 2024) distributed nationwide in the USA. The specific product code is L5B5193 (NDC 0941-0411-07).
Healthcare providers and facilities currently using or storing this lot should cease use and contact Baxter Healthcare for guidance on replacement or return. Patients undergoing peritoneal dialysis should contact their healthcare provider if they have questions about whether this recall affects their treatment.
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
- Affected units
- 22,112
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 (2)
- Lot Y406734
- Exp 31-Oct-2024
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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