Reported Feb 27, 2019 · Terminated
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution…
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 · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Kaguya Automated Peritoneal
- Dialysis System Product UsageIt is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis
- Lot codes and dates
- Product code T5C8500. All serial numbers are affected.
- Amount recalled
- 1,085 devices
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
Why it was recalled
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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