Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter

Baxter International Inc. has voluntarily initiated a recall in the US of two lots of Dianeal Low Calcium (2.5 mEq/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 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 US.

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 30 May 2014 and 9 July 2014.