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Baxter Healthcare's IIPV product recall of HomeChoice peritoneal dialysis cyclers classified as Class I recall

Published on March 3, 2010 at 3:07 AM · No Comments

Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue.

“We stand ready to support our patients and the nephrology community as we develop and implement measures intended to reduce the occurrence of IIPV.”

Source Baxter International Inc.,

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Posted in: Device / Technology News | Medical Procedure News

Tags: Abdominal Pain, Biotechnology, Blood Pressure, Catheter, Dialysis, Edema, Heart Failure, Heart Rate, Hemophilia, Hospital, Nephrology, Renal Failure, Trauma, Vomiting

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