Dianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks
Baxter Healthcare recalls 6,874 bags of Dianeal Low Calcium peritoneal dialysis solution due to potential leaks in the connector assembly that could compromise product sterility.
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 designation without reported hospitalizations, illnesses, or confirmed contamination applies. The hazard involves potential sterility compromise in a critical dialysis solution—a risk-of-harm product—but no patient harm has been reported in the source, constraining severity to High rather than Severe.
Plain-English summary
Baxter Healthcare Corporation is recalling 6,874 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution, a prescribed medication for patients undergoing peritoneal dialysis. The affected product is Lot R24B25FA with an expiration date of February 28, 2026. The product is supplied in 6,000 mL sterile bags intended for intraperitoneal administration.
The recall was issued due to a lack of assurance of sterility. The specific defect is the potential presence of leaks originating from the connector assembly component. These leaks could compromise the sterile integrity of the dialysis solution.
Patients using peritoneal dialysis who have received product from this lot should consult with their healthcare provider or dialysis center immediately. Healthcare facilities should discontinue use of affected product and contact Baxter Healthcare for replacement options. The recall affects products distributed in the United States and Canada.
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
- Affected units
- 6,874
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 R24B25FA
- Exp. 2/28/2026
Distribution
Distributed nationwide across the United States.
Related recalls
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Similar recalls
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