Baxter HomeChoice PD System Recall: Risk of Air Delivery if Cassettes Damaged
Baxter recalls HomeChoice Automated PD systems (models 5C4471, 5C4471R) due to risk of air delivery into patients if cassettes are damaged during setup. Affected users should check for improper packaging opening.
Use caution until it’s fixed
Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operator s Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.
Contact the company
What happened, in plain English
Baxter is recalling HomeChoice Automated PD systems (models 5C4471, 5C4471R) because users might damage cassettes by incorrectly opening packaging with sharp objects. This could cause the device to deliver air into the patient during dialysis, potentially causing serious harm. Read more at govinfonow.com/recall/73465-baxter-homechoice-pd-system-recall-risk-of-air-delivery-if.
Source Summary by GovInfoNow · govinfonow.com/recall/73465-baxter-homechoice-pd-system-recall-risk-of-air-delivery-if · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3040-2017
Cite this page
“Baxter HomeChoice PD System Recall: Risk of Air Delivery if Cassettes Damaged.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73465-baxter-homechoice-pd-system-recall-risk-of-air-delivery-if. Based on FDA recall #Z-3040-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3040-2017%22&limit=1).
Why it’s dangerous
If cassettes are damaged during setup by using sharp objects to open packaging, the device may not detect small holes or cuts in the cassette. This can cause air to be delivered into the patient during dialysis, which could lead to serious complications.
Who’s affected
Patients using Baxter's HomeChoice Automated PD systems for peritoneal dialysis are most at risk. The recall affects users who have the specific model numbers 5C4471 or 5C4471R.
How to tell if you have this one
Check for the model numbers 5C4471 or 5C4471R on the HomeChoice Automated PD system. The product is used for peritoneal dialysis in patients with renal failure.
- Brand
Baxter Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3040-2017 | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.; all codes | 15144 units |
| Z-3041-2017 | HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.; all codes | 23732 units |
What to do — step by step
Check Cassettes for Damage
Inspect the cassettes for signs of damage from improper packaging opening with sharp objects.
Follow Operator Manual Instructions
Use the Operator's Manual to correctly open disposable set packaging without sharp objects.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3040-2017 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3040-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.