Baxter Initiates US Voluntary Recall of One Lot of Peritoneal Dialysis Solution Due to Container-Closure Non-Integrity

Baxter International Inc. has initiated a voluntary recall in the US of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000 mL (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 US.

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.

This recall is being conducted with the knowledge of FDA.