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Peritoneal Dialysis Solution Recall for Infection Risk

Peritoneal Dialysis Solution Recall for Infection Risk

March 7, 2014 — Baxter International has recalled one lot of DIANEAL PD-2 Peritoneal Dialysis Solution after receiving customer complaints of particulate matter, confirmed as mold.

Peritoneal dialysis solution is injected directly into a patient’s body cavity (peritoneum). Moldy products could potentially cause a life-threatening fungal peritoneal infection (fungal peritonitis) or sepsis (blood poisoning). Baxter has received reports of adverse events but “no causal relationship has been established.”

Recalled Baxter peritoneal dialysis solution:

  • DIANEAL PD-2 Peritoneal Dialysis Solution — With 1.5% Dextrose 6000mL (Ambu-Flex II) — Affected lot is C903799, expiration 05/15 (product code L5B9710), NDC 00941-0411-11. Packaged in flexible plastic containers and distributed to dialysis clinics in the United States between May 2013 and January 2014.

Recommendation

If you are a patient who has received a contaminated peritoneal dialysis solution, contact a healthcare professional immediately if you have any problems or symptoms of an infection or sepsis that may be related to the use of this product. You can also contact Baxter Home Care Services at 1-800-284-4060.

If you are a healthcare professional who has purchased the contaminated peritoneal dialysis solution, you can return it for credit to Baxter by calling 1-888-229-0001. The company will also replace unaffected lots of the product.

What is Fungal Peritonitis?

Fungal peritonitis is becoming more common in patients with end-stage kidney failure managed by continuous peritoneal dialysis. The complication is rare, but between 20-30% of cases cause severe infection or death. If the infection is not deadly, the inflammation usually causes irreversible damage to the peritoneal membrane.

Signs & symptoms:

  • 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

Do I have a Peritoneal Dialysis Solution Lawsuit?

The Schmidt Firm, PLLC is currently accepting peritoneal dialysis solution induced injury cases in all 50 states. If you or somebody you know has been injured by a fungal infection or sepsis caused by moldy dialysis solution, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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