Baxter Healthcare Corporation recalls HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler i…

Recall date

July 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3040-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Worldwide Distribution

Why it was recalled

Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.