CONTAINER-CLOSURE NON-INTEGRITY APPEARS TO PERMIT MOLD GROWTH
Baxter International Inc initiated a recall for a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose. While the recall is due to non-integrity of the container-closure, it appears that complaints of particulate matter, identified as mold, were growing within the 6000 mL bags from the leak to the container. Based on the comments within the recall, it appears that more than one complaint has been filed. Please see the entire recall notice below.
FOR IMMEDIATE RELEASE - March 5, 2014 – DEERFIELD, Ill.,– Baxter International Inc. announced today it has initiated a voluntary recall in the United States of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated as a result of complaints of particulate matter, identified as mold, resulting from a leak in the container.
Intraperitoneal administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis. Baxter has received reports of adverse events for this lot of DIANEAL PD Solution; no causal relationship has been established between the events and this recall to date.
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, expiration 05/15 (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 in the United States.
Baxter notified customers by recall letter to instruct customers to locate and remove any affected product from their facility. All patients who received product from the affected lot 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 lot was distributed to customers between May 2013 and January 2014. Unaffected lot numbers can continue to be used according to the instructions for use. Healthcare providers who received affected product should return it to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.