Baxter announced a voluntary recall of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II). The recall was initiated after particulate matter, identified as mold, was found due to a leak in the container. DIANEAL is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on PD therapy.
The one affected lot is C903799, with an expiration of May 2015 (product code L5B9710), NDC 00941-0411-11. Product affected by this recall was packaged in flexible plastic containers and distributed to dialysis centers, facilities, distributors and patients between May 2013 and January 2014.
Intraperitoneal administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.
Healthcare providers who received affected product should return it to Baxter for credit by contacting Baxter Healthcare Center for Service.
For more information call (888) 229-0001 or visit Baxter.com.