August 15, 2014 — Baxter International Inc. has issued a recall for DIANEAL Peritoneal Dialysis Solution due to the risk of infection and inflammation from contaminants, including oxidized stainless steel, garment fiber, and PVC particulate matter.
The recall affects Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II). Specific lot numbers and product codes are listed in the recall notification.
No adverse events have been reported, but the FDA warns:
“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.”
Second Dianeal Recall from Baxter This Year
In March 2014, Baxter issued a Class I recall for DIANEAL dialysis solution after receiving customer complaints about visible mold contamination. Adverse events were reported but Baxter did not establish cause-and-effect. The FDA warned about the risk of fungal infections (fungal peritonitis) and blood poisoning (sepsis). Click here to read more.
What is Dianeal?
DIANEAL is used in patients with end-stage kidney failure who are undergoing peritoneal dialysis (PD). This procedure involves injecting the Dianeal solution into the patient’s abdominal cavity, where it absorbs toxins and excess fluid from the patient’s blood before being drained away. This therapy replaces the function of the kidneys.
Do I have a Dialysis Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting dialysis induced injury cases in all 50 states. If you or somebody you know has been injured by an infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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