Reported Dec 2, 2015 · Terminated
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
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 - Model no. NX1000-3. For home hemodialysis.
- Lot codes and dates
- Software version 4.9 and 4.10
- Amount recalled
- 2,134 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new NxStage Medical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.