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.
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 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
- Affected units
- 9,788
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.
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
- HighDianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks
FDA (Drugs) · 2024-07-17
- HighDIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise
FDA (Drugs) · 2023-09-06
- HighDianeal Peritoneal Dialysis Solution Recalled for Potential Sterility Compromise
FDA (Drugs) · 2023-09-06
- HighDianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss
FDA (Drugs) · 2023-05-03
- SevereBaxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns
FDA (Drugs) · 2019-01-16
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Same hazard · sterility risk
See all →- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighMedline Medical Procedure Kits Recalled for High Endotoxin Levels
FDA (Devices) · 2026-05-06
- HighCook Medical tracheostomy introducer sets labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
Similar recalls
- HighDianeal Peritoneal Dialysis Solution Recalled for Potential Sterility Compromise
FDA (Drugs) · 2023-09-06
- HighDIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise
FDA (Drugs) · 2023-09-06
- SevereBaxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns
FDA (Drugs) · 2019-01-16
- HighDianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks
FDA (Drugs) · 2024-07-17
- CriticalBaxter Recalls Dianeal Peritoneal Dialysis Solution Due to Mold Contamination
FDA (Drugs) · 2014-05-07
- HighBaxter Recalls DIANEAL Low Calcium Peritoneal Dialysis Solution Due to Container Defect
FDA (Drugs) · 2013-08-07