Reported Aug 11, 2021 · Terminated
Kaguya Automated Peritoneal Dialysis System
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BAXTER HEALTHCARE CORPORATION · 25212 W Il Route 120 · Round Lake, IL · 60073-9799
Is this the product you have?
- Kaguya Automated Peritoneal Dialysis System
- Lot codes and dates
- Product Code T5C8500 (distribution in Japan only)
- Amount recalled
- 5101 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
This product could cause temporary or reversible health problems — stop using it.
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