On March 2 2010, FDA designated Baxter International’s January Feild Corrective Action of HomeChoice and HomeChoice PRO automated peritoneal dialysis cyclers a Class I recall. A Class I recall is the U.S. Food & Drug Administration (FDA) most serious type of recall action, and are usually only issued when a device poses a risk of serious injury or patient death.
Baxter and the FDA are conducting the recall of the HomeChoice and HomeChoice PRO devices due to reports of serious injuries and at least one death associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
The recall notice says that Baxter will not be removing the HomeChoice and HomeChoice PRO from the market, however clinicians should weigh the risks and benefits to continued use of these devices. The notice goes on to say that clinicians should also review the prescription settings for patients who continue to use these devices.