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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
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