Is 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.
recalled?

Question

Is 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.
 recalled?

Accepted Answer

Recall reasons:
• Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators 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.
• 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.

Status: Voluntary: Firm initiated

Initial Firm Notification: Letter

Distribution: Worldwide Distribution

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Affected Products

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