Z-1019-05

HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation...

Name: Z-1019-05 HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation...
Creator: Baxter Healthcare Renal Div
Published: 2005-06-21
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2005-06-21 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog... on 2005-06-21. The reason FDA records is "The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an elcetric shock hazard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1019-05
Status: Terminated
Initiated: 2005-06-21
Posted: 2005-07-19
Terminated: 2007-12-11
Recalling firm: Baxter Healthcare Renal Div
Product: HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an elcetric shock hazard.
FDA root cause: Other
Action: Baxter sent Urgent Device Correction letters worldwide to their customers on 6/21/05 and home patients on 6/22/05. The accounts were informed of teh risk of electrical shock from screws used to secure the Power Entry Module to the back of the HomeChoice system, and were instructed to always connect the power cord to the power entry module first, before plugging the power cord into a grounded electrical outlet. The users were advised to use caution to avoid contact the power entry module screws while powering on or powering off the device, and were informed that a new mounting bracket that providews more reliable grounding was installed in instruments processed through the Baxter service organization as of May 2005. All remaining instruments will receive the new mounting bracket by August 2006, and Baxter will contact the accounts to arrange for the upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.
Quantity in commerce: 20,133 units
Distribution: Nationwide, including Puerto Rico, and internationally to Argentina, Austria, Australia, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, Ireland, India, Italy, Korea, Mexico, Malaysia, Nicaragua, the Netherlands, New Zealand, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Kingdom, Uruguay and Venezuela.
Product codes and lots: all serial numbers

Product code FKX

K012988Class IIHomechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469Baxter Healthcare Corp / cleared 2001-12-05

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)