# FDA recall Z-3041-2017

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2017-07-05.

## Product

HomeChoice Pro Automated PD system Model numbers:  5C8310, 5C8310R    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

Worldwide Distribution

## Key facts

- **Recall number:** Z-3041-2017
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-05
- **Report date:** 2017-08-23
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3041-2017

## Citation

> AI Analytics. FDA recall Z-3041-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3041-2017. Source: US FDA. Licensed CC0.

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