Z-3041-2017Class II

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

Name: Z-3041-2017 HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R
Creator: Baxter Healthcare Corporation
Published: 2017-07-05
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2017-07-05 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corporation began a recall of HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of... on 2017-07-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3041-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-05
Posted: 2017-08-16
Terminated: 2020-10-05
Recalling firm: Baxter Healthcare Corporation
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.
Product code: FKX System, Peritoneal, Automatic Delivery
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.
Root cause tag: packaging
FDA root cause: Use error
Action: The firm notified their consignees by letter on 07/05/2017 of the potential for damaging the disposable set if tools are used to open the packaging and directing them to only open the packaging by hand by letter.
Quantity in commerce: 23732 units
Distribution: Worldwide Distribution
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3041-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3040-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-15
Z-3041-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-15

Product code FKX

K102936Class IIHomechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471r and 5C8310rBaxter Healthcare Corp / cleared 2011-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)