NxStage recalls low volume cartridges for home hemodialysis in patients with low blood volume (2.4L or less, under 30kg) to prevent health risks during dialysis treatments.
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.
NxStage is recalling low volume cartridges used with specific home dialysis machines. These cartridges may cause health risks for patients with very low blood volume (2.4 liters or less) who weigh 30kg or less during home dialysis treatments.
The cartridge may deliver larger dialysate volumes than needed for patients with very low blood volume, potentially causing health risks during home dialysis treatments. This risk is specific to patients weighing 30kg or less with blood volume under 2.4 liters.
Patients with low blood volume (2.4 liters or less) and body weight under 30kg using home hemodialysis with these cartridges are most at risk. The affected devices include specific NxStage One and VersiHD Cycler models.
Check for the cartridge model CAR-125-B with the following device models: NxStage One (NX1000-1, NX1000-3, NX1000-10), NxStage VersiHD Cycler (NX1000-16, NX1000-16-A), or the listed UDI numbers and lot numbers.
Identify if your cartridge is CAR-125-B used with the specified device models.
Reach out to NxStage Medical Inc for guidance on whether your cartridge needs replacement.
The recall does not require immediate stop use; patients should contact NxStage Medical Inc for specific guidance.
Patients with blood volume under 2.4 liters and body weight under 30kg during home hemodialysis.
Check for the cartridge model CAR-125-B with the listed device models or UDI numbers and lot numbers.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-0697-2020 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-0697-2020 from NxStage. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
