Reported Dec 25, 2019 · Terminated
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage…
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 St · Lawrence, MA · 01843-1748
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
NX1000-1 | NxStage One |
| — | NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A |
| — | NxStage One, Model Numbers: NX1000-3 and NX1000-3-A |
| — | NxStage One, Model Numbers: NX1000-10 and NX1000-10-A |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 UDI # - M535NX100010 Product 2 UDI # - M535NX1000160 and M535NX100016A0 Product 3 UDI # - M535NX100030 and M535NX10003A0 Product 4 UDI # - M535NX1000100 and M535NX100010A0 Lot Numbers: 60677021, 60877053, 70477033, 71177020, 80377002, 80477018, 80877011, 81077018, 81177047, 90277048 and 90677002 - Amount recalled
- 1803 units
Where it was sold
Why it was recalled
There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.
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 infant & baby 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.