Baxter International, a global, diversified healthcare company, announced that the company has  voluntarily initiating a recall in the United States of two lots of Dianeal Low Calcium (2.5mEq/L) peritoneal dialysis Solution with 2.5 per cent Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidised stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process.

To date, 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.

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.

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.

The number of individual units within these two lots represents less than one percent of Baxter's average annual units produced globally. Unaffected lot numbers can continue to be used according to the instructions for use.

Baxter notified customers by recall letter to instruct them to locate and remove any affected product from their facility. All patients who received product from the affected lots also were contacted by recall letter and provided instructions to arrange for product return. Dialysis centers, facilities, distributors, and patients should stop use and return to place of purchase. The affected lots were distributed to customers between May 30, 2014 and July 9, 2014.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.