Peritoneal dialysis solution recalled due to sterility assurance concerns
Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.
What this means for you
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 involving a critical medical product (peritoneal dialysis solution) where potential sterility-compromising leaks have been identified. No illnesses or injuries have been reported; the hazard is theoretical and the recall is preventive.
Plain-English summary
Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose, a peritoneal dialysis solution in 3000 mL Ambu-Flex II bags. The recall affects Lot Y405201 (expiration 31-Oct-2024) distributed nationwide in the United States.
The recall was initiated due to lack of assurance of sterility. Potential leaks have been identified as originating from the Luer component of the product bags. This could compromise the sterility of the dialysis solution.
Dianeal Low Calcium with Dextrose is a prescription peritoneal dialysis solution used in the treatment of kidney failure. Patients and healthcare providers should be aware of this recall when handling the affected product lot.
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
- Hazard
- sterility-risk
- container-leak
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 Y405201
- Exp 31-Oct-2024
Distribution
Distributed nationwide across the United States.
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