Baxter Recalls Dianeal Low Calcium Peritoneal Dialysis Solution Bags
Baxter Healthcare is recalling 50,530 bags of Dianeal Low Calcium peritoneal dialysis solution due to the presence of particulate matter found during manufacturing.
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 FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Baxter Healthcare Corporation is recalling 50,530 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution. The product is a prescription-only intraperitoneal solution packaged in 5,000 mL Ambu-Flex II container bags. The recall affects specific lots (C940700 and C940841) with an expiration date of 05/16, which were distributed nationwide.
The recall was initiated because particulate matter was found during the manufacturing process. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
Patients using this product should stop using the affected lots and contact their healthcare provider or Baxter Healthcare for further instructions. The affected product is identified by NDC 0941-0457-05 and Product Code L5B5202.
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.
- Hazard
- Affected units
- 50,530
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 (3)
- Lot #: C940700
- C940841
- Exp 05/16
Distribution
Distributed nationwide across the United States.
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