Home / Recalls / Baxter Healthcare Corporation / Z-3040-2017

Z-3040-2017 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
August 23, 2017
Initiation Date
July 5, 2017
Termination Date
October 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15144 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution

Code Information

all codes

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