HomeChoice Automated Peritoneal Dialysis Systems recallZ-0564-03 · Baxter Healthcare Corp. · initiated Dec 23, 2002
Terminated All recalls posted in February 2003
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 Corp. 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
Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
FDA root cause category: Other
What the company is doing
Safety Alert letters dated 12/23/02 were mailed to the medical directos of facilities identified as having patients who use the low fill volume cassette with the HomeChoice machines. The letters informed them of the potential low ultrafiltrate volumes and requested that they review the patient list provided with the letter and verify that all of their patients who use the device in the low fill mode are included.
Recall details
- Recall number
- Z-0564-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 23, 2002
- Posted by the FDA
- Feb 21, 2003
- Recalling firm
- Baxter Healthcare Corp.
- Product code
- FKX
- FDA submissions
- K012988
- Distribution
- Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom.
Product description
HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R
Code information (models, lots, serial numbers)
All HomeChoice Systems with software versions 8.51 and 8.52.
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
Other products in the same recall event
The FDA groups related products into one recall event (event 25284).
- Z-0565-03 · TerminatedHomeChoice 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, R…
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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