Baxter International is recalling two lots of Dianeal Low Calcium Peritoneal Dialysis Solution with 2.5 percent Dextrose 5000mL (Ambu-Flex II) because oxidized stainless steel, garment fiber and PVC particulate matter was present during the manufacturing process and seen floating in the solution. If the particulate within the solution is injected into patients it could cause local inflammation with foreign body reaction or result in adhesion formation. The matter could also potentially serve as a focal point for infection should any existing pre-existing peritonitis exist, which could be deadly to patients receiving the solution.
The product labeling advises health care providers to inspect the solution containers visually for signs of leakage prior to use. Solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage should not be used.
The recall involves lots C940700 and C940841 of Baxter International’s Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II), which were distributed to customers between May 30, 2014, and July 9, 2014. The solution is used during peritoneal dialysis treatment for patients with severe chronic kidney disease.
The affected products were distributed to dialysis centers, facilities, distributors and patients throughout the United States. Customers were informed of the recall by letter and instructed them to locate and remove any affected product from their facility. Dialysis centers, facilities, distributors and patients should stop using the products and return them to the place of purchase.
Any side effects or quality issues with this product should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.