Class 1 Recall of Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems

Washington, DC: FDA and Baxter notified healthcare professionals of a Class I recall of the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems, which are prescription medical devices used to treat pediatric and adult patients with kidney failure.

Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.

IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.

Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.

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Published on Mar-4-10