Baxter Healthcare Renal Div 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
All Spanish language Patient At-Home Guides
Products Sold
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
Baxter Healthcare Renal Div is recalling Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis System due to The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English versio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026