FDAFDA · Food and drugs·Recall number Z-0697-2020
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;
Published December 25, 2019 · Recall initiated: August 27, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NxStage Medical, Inc.
- Distributor
- AL, AZ, CA, NC & VA
- Lot
- Product 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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