HomeChoice PRO Automated Peritoneal Dialysis Systems recallZ-0397-05 · Baxter Healthcare Renal Div · initiated Dec 23, 2004
Terminated All recalls posted in January 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
A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.
FDA root cause category: Other
What the company is doing
Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04. The patients in Denmark and Sweden will be re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs. Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to break all peel-seals prior to use. Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented. The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.
Recall details
- Recall number
- Z-0397-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 23, 2004
- Posted by the FDA
- Jan 15, 2005
- Recalling firm
- Baxter Healthcare Renal Div
- Quantity
- 165 units
- Product code
- FKX
- FDA submissions
- K012988
- Distribution
- Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.
Product description
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
Code information (models, lots, serial numbers)
Units with software version 8.7 used with Physioneal Clear-Flex PD products
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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