Baxter Initiates Voluntary Recall of Two Lots of Peritoneal Dialysis Solution

Baxter International Inc. is voluntarily initiating a recall in the United States of two lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000 mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and polyvinyl chloride particulate matter identified during the manufacturing process.

The number of individual units within these two lots represents less than 1% of Baxter's average annual units produced globally. To date, Baxter says that no adverse events or related product complaints have been associated with the recalled products, which were distributed to dialysis centers, facilities, distributors, and patients in the United States.

Dianeal is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on peritoneal dialysis therapy. PD therapy is performed by using the body's peritoneal membrane as a filter while special solution and osmotic pressure help remove extra fluids and clean the blood. This process takes the place of what healthy kidneys do for the body.

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.

Source: Baxter International


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