NxStage Low Volume Cartridge Recalled for Hemodialysis Risk
NxStage Medical is recalling Low Volume Cartridge IFUs due to a potential health risk for low-volume patients using larger dialysate volumes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source describes a 'potential patient health risk' for a specific patient population without reporting specific injuries or illnesses, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
NxStage Medical, Inc. is recalling 1,803 units of the Low Volume Cartridge IFU (SKU CAR-125-B). This product is used with several NxStage hemodialysis devices, including the NxStage One and NxStage VersiHD Cycler models.
The recall is issued because there is a potential patient health risk when performing chronic hemodialysis treatments in the home setting. The risk specifically applies to patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when larger dialysate volumes are prescribed.
The affected units were distributed in Alabama, Arizona, California, North Carolina, and Virginia. Consumers and healthcare providers should stop using the affected cartridges and contact NxStage Medical for instructions on the recall.
The recalled product
- Product
- 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…
- Manufacturer
- NxStage Medical, Inc.
- Hazard
- Affected units
- 1,803
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 60877053
- 70477033
- 71177020
- 80377002
- 80477018
- 80877011
- 81077018
- 81177047
- 90277048 and 90677002
Distribution
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