Baxter Healthcare Corporation: Medical Device Recall in 2017 - (Recall #: Z-3041-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 5, 2017

Date Posted: August 23, 2017

Recall Number: Z-3041-2017

Event ID: 77711

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.

Status: Terminated

Product Quantity: 23732 units

Code Information:

all codes

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated