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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