Z-0800-2010

HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R...

Name: Z-0800-2010 HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R...
Creator: Baxter Healthcare Renal Div
Published: 2010-01-08
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2010-01-08 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Renal Div began a recall of HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis... on 2010-01-08. The reason FDA records is "Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0800-2010
Status: Terminated
Initiated: 2010-01-08
Posted: 2010-03-01
Terminated: 2017-06-21
Recalling firm: Baxter Healthcare Renal Div
Product: HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. The HomeChoice PRO model has a PRO card, a small electronic data card, which stores information from the nurse or doctor and automatically sets up the system for the patient.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Urgent Product Recall letters dated January 8, 2010 were mailed to all Peritoneal Dialysis Clinicians on January 8, 2010 and letters dated January 12, 2010 to all Home Care Coordinators and Home Dialysis Patients on January 12, 2010, informing them of steps to take to help reduce or eliminate overfill, also referred to as Increased Intraperitoneal Volume, associated with HomeChoice/Homechoice Pro cyclers. Baxter Healthcare Corporation explained that they had received complaints of IIPV. The accounts were requested to complete and return the enclosed response form, indicating that they received and understood the notification, and if they still had a HomeChoice System or not. Any questions from the Home Care Coordinators are to be directed to the Baxter Global Technical Services at 1-800-553-6898.
Quantity in commerce: 32,678 units
Distribution: Worldwide Distribution -- United States, Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom and Venezuela.
Product codes and lots: All serial numbers.

Product code FKX

K053512Class IIHomechoice/homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310Baxter Healthcare Corp / cleared 2006-02-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)