August 15, 2014 — Baxter International Inc. is recalling DIANEAL Peritoneal Dialysis Solution because it may be contaminated with particles of oxidized stainless steel, garment fiber, and PVC particulate matter. This is the second time Baxter has recalled dialysis solution this year.
- DIANEAL: Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II). Click here for specific Lots and Product Codes.
No adverse events or complaints have been linked to the recalled products. However, it is possible that life-threatening infections or other adverse events could occur. According to the FDA:
“Intraperitoneal administration of a product with particulate matter may cause local inflammation with foreign body reaction or result in adhesion formation. The particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.”
What is Dianeal?
DIANEAL is a peritoneal dialysis (PD) solution that is used in patients with end-stage kidney failure. Treatment involves injecting the solution into the patient’s abdominal cavity. It absorbs toxins and excess fluids from the blood and is drained away.
Baxter’s Second Dianeal Recall this Year
This is not the first time Baxter has recalled Dianeal solution this year. In March, Baxter issued a Class I recall after receiving customer complaints about mold resulting from a leak in the container. Baxter received adverse event reports but could not confirm a causal relationship. Patients who received moldy infusions could develop life-threatening fungal infections (fungal peritonitis) or blood poisoning (sepsis). Click here to read more.
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