A Class I recall was initiated January 8, 2010 for the Baxter Healthcare Corp HomeChoice and HomeChoice PRO automated peritoneal dialysis (PD) systems.

Baxter recalled the products because of reports of serious injuries and at least one death associated with increased intraperitoneal volume (IIPV), also known as overfill of the abdominal cavity. IIPV can cause serious breathing and heart problems that can result in serious injury or death.

Distributed since 1994, the HomeChoice and HomeChoice PRO automated PD systems are prescription medical devices used to treat pediatric and adult patients with kidney failure. Although Baxter is not removing the HomeChoice and HomeChoice PRO from the market, clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. Clinicians should also review the prescription settings for patients who continue to use these devices.

Any adverse reactions experienced with the use of this product or quality problems should be reported to the Baxter renal division at (888) 736-2543, prompt 3 (corporate product surveillance), and the FDA’s MedWatch Program at (800) FDA-l088. If you need assistance with your HomeChoice or HomeChoice PRO, call the Baxter customer service line, available 24 hours and day, 7 days a week at (800) 553-6898.

SPONSORS