Dianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution nationwide due to potential leaks from the container that could compromise sterility. Affected patients should contact their healthcare provider.
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 of an injectable solution where loss of sterility could result in serious infection. While no illnesses have been reported, the potential for harm is significant given the critical nature of maintaining sterility in peritoneal dialysis solutions.
Plain-English summary
Baxter Healthcare Corporation is recalling Dianeal Low Calcium with Dextrose peritoneal dialysis solution nationwide due to potential leaks originating from the Luer component. These leaks could compromise the sterility assurance of the solution.
The recall affects approximately 95,448 bags of 5000 mL and 174,522 bags of 6000 mL packaged in Ambu-Flex II container bags. Affected lot numbers include Y406130 (5000 mL bags) and Y406314, Y406314A, Y406963, and Y407199 (6000 mL bags), all with an expiration date of October 31, 2024.
Patients currently using or about to use affected lots should contact their healthcare provider or dialysis facility immediately. Do not use recalled product. Healthcare providers should verify whether they have received affected lots and implement appropriate disposal or return procedures as directed by Baxter Healthcare.
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
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 (6)
- Lot #: a) Y406130
- Exp 31-Oct-2024
- b) Lots Y406314
- Y406314A
- Y406963
- Y407199
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
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