Spanish Patient At-Home Guide for the HomeChoice/HomeChoice… recallZ-0139-06 · Baxter Healthcare Renal Div · initiated Sep 12, 2005
Terminated All recalls posted in November 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Renal Div or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0139-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 12, 2005
- Posted by the FDA
- Nov 16, 2005
- Recalling firm
- Baxter Healthcare Renal Div
- Quantity
- 524 manuals
- Product code
- FKX
- FDA submissions
- K012988
- Distribution
- Nationwide
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K012988 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LOW RECIRCULATION VOLUME APD SET 5C8302CBaxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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