Z-0139-06

Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems...

Name: Z-0139-06 Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems...
Creator: Baxter Healthcare Renal Div
Published: 2005-09-12
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2005-09-12 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation... on 2005-09-12. The reason FDA records is "The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0139-06
Status: Terminated
Initiated: 2005-09-12
Posted: 2005-11-16
Terminated: 2006-07-19
Recalling firm: Baxter Healthcare Renal Div
Product: Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine.
FDA root cause: Other
Action: An Urgent Device Correction letter was sent in Spanish and English, along with the new Spanish Patient At-Home Guide, item 157-1260-806ES, to Spanish-only speaking customers and their affiliated facilities on 9/12/05. The letters highlighted the additions to the Patient At-Home Guide and asked the customers to review them carefully and to use the new guide from this point forward to assist them in the safe and effective operation of their HomeChoice/HomeChoice PRO machine. They were instructed to discard any previous versions of the guide. Any questions were directed to Baxter DIalysis Patient Services at 1-800-2824-4060.
Quantity in commerce: 524 manuals
Distribution: Nationwide
Product codes and lots: All Spanish language Patient At-Home Guides, with item numbers other than item #157-1260-806ES Rev. A 7/04 printed on teh back cover of the manual

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)