Reported Dec 2, 2015 · Terminated
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
NxStage Medical, Inc.
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: NxStage Medical, Inc. · 350 Merrimack Street · Lawrence, MA · 01843-1748
Is this the product you have?
- NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
- Lot codes and dates
- Software version 4.9 and 4.10
- Amount recalled
- 7 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
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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