Baxter Recalls Moldy Peritoneal Dialysis Solution

March 7, 2014 — Baxter International has issued a recall of DIANEAL PD-2 Peritoneal Dialysis Solution after receiving complaints about particulate matter, identified as mold, resulting from a leak in the container.

Baxter has received adverse event reports for this lot of dialysis solution, but has not established a causal relationship. Patients who receive an intraperitoneal injection (into the body cavity) that is contaminated with mold could potentially develop a life-threatening fungal infection (fungal peritonitis) or sepsis (blood poisoning).

Recalled products include:

• DIANEAL Peritoneal Dialysis (PD) Solution for use in patients with chronic kidney failure who are on dialysis. The affected lot is C903799, expiration 05/15 (product code L5B9710), NDC 00941-0411-11. Products were packaged in flexible plastic containers and distributed to dialysis clinics throughout the United States between May 2013 and January 2014.

What Should I Do?

Healthcare professionals should locate and remove any affected products from their facility. Customers who received the recalled containers can return it to Baxter for credit by calling the Baxter Healthcare Center for Service at (888) 229-0001.

Patients who received the contaminated solution should contact their physician if they have any problems that might be related to taking this product. Patients with questions regarding this recall or requiring replacement product can call Baxter Home Care Services at 1-800-284-4060.

What is Fungal Peritonitis?

Fungal peritonitis is a fungal infection of the peritoneum (body cavity). It is becoming increasingly common in people with end-stage kidney failure who are managed by continuous peritoneal dialysis. Although rare, severe infection or death occurs in 20-30% of patients, or even higher in some clinics. Even non-fatal infections permanently damage the peritoneal membrane.

Symptoms of fungal peritonitis:

• Swelling and tenderness in the abdomen
• Fever and chills
• Loss of appetite
• Thirst
• Nausea and vomiting
• Less urine
• Not being able to pass gas or stool

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