Baxter Recalls Dianeal Peritoneal Dialysis Solution Due to Mold Contamination
Baxter Healthcare is recalling 27,169 containers of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to reported leaks and mold contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of mold in a sterile dialysis solution is a critical hazard.
Plain-English summary
Baxter Healthcare Corp. is recalling 27,169 containers of Dianeal Low Calcium with Dextrose peritoneal dialysis solution. The affected product is the 6,000 mL Ambu-Flex II container, prescription only, with product code L5B9710 and NDC 0941-0411-11. The specific lot number is C903799, with an expiration date of 05/15.
The recall was initiated due to complaints of leaks and the identification of particulate matter, specifically mold, in the solution bag and the overpouch. This non-sterility issue poses a risk to patients using the solution for peritoneal dialysis.
The product was distributed nationwide. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be stopped and returned to the pharmacy or supplier for replacement or refund.
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 Corp.
- Affected units
- 27,169
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 number: C903799
- Exp 05/15
Distribution
Distributed nationwide across the United States.
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
- HighPeritoneal dialysis solution recalled due to sterility assurance concerns
FDA (Drugs) · 2023-05-03
- HighDianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss
FDA (Drugs) · 2023-05-03
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · mold contamination
See all →- CriticalAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-30
- SevereAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-23
- HighTurmeric capsules recalled over mold contamination in raw material lots
FDA (Food) · 2026-02-04
- ModeratePariva Marinated Labneh Bites Recalled for Potential Mold Contamination
FDA (Food) · 2024-08-21
- HighPariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination
FDA (Food) · 2024-08-21
Similar recalls
- CriticalBaxter Recalls Dianeal Low Calcium Peritoneal Dialysis Solution Bags
FDA (Drugs) · 2014-10-08
- SevereBaxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns
FDA (Drugs) · 2019-01-16
- HighBaxter Recalls DIANEAL Low Calcium Peritoneal Dialysis Solution Due to Container Defect
FDA (Drugs) · 2013-08-07
- HighDianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss
FDA (Drugs) · 2023-05-03
- 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