Every recall we track for NxStage Medical Inc — 16 in all — plus the complaints and injury reports the public filed about them.
NxStage recalls PureFlow-B Solution with catalog numbers RFP-400 to RFP-456 due to potential perimeter seal failure causing electrolyte fluid splash to user's face during mixing. Affected units include specific lot numbers.
NxStage recalls PureFlow-B Solution dialysate bags with catalog numbers RFP-400 to RFP-456 due to small chamber bursting during mixing, risking skin/eye contact or slips from spilled fluid.
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.
NxStage recalls PureFlow B Solution (lot Q1811792) due to mislabeling with incorrect product numbers. This may cause confusion in hemodialysis treatments. Affected units should be checked for lot numbers.
NxStage recalls specific lots of PureFlow B Solution (Q1811789 & Q1811790) due to mislabeling. This could lead to incorrect product use in hemodialysis. Affected users should check their lot numbers.
NxStage recalls PureFlow B Solution-RFP-403 for potential eye/skin injury if small chamber bursts during hemodialysis. Learn about affected lots and safety steps.
NxStage recalls specific lots of PureFlow B Solution-RFP-406 for hemodialysis. Small chamber bursting could cause injury if electrolyte fluid contacts skin or eyes.
NxStage recalls specific lots of PureFlow B Solution for hemodialysis that may burst, causing injury if electrolyte fluid contacts skin or eyes. Affected units include lots F1708230-F1711345 and Q1711844-Q1804888.
NxStage recalls specific lots of PureFlow B Solution for hemodialysis. Small chamber bursting may cause electrolyte fluid injury to eyes or skin. Affected lots: Q1801222, Q1801341, Q1802396, Q1802397.
NxStage PureFlow B Solution-RFP-401 for hemodialysis may burst, causing injury if electrolyte fluid contacts skin or eyes. Affected lots listed. Stop using immediately.
NxStage PureFlow B Solution-RFP-RFP-456 premixed dialysate for hemodialysis recalled due to risk of small chamber bursting and causing injury if electrolyte fluid contacts eyes or skin. Lot numbers F1708258, F1710322, Q1711910, Q1711911, Q1712093, Q1801227, Q1801342, Q1801343, Q1802393, Q1803816.
NxStage recalls PureFlow B Solution-RFP-400 dialysate bags with risk of small chamber bursting, causing injury if contact with eyes/skin occurs. Affected lot numbers listed.
NxStage recalls specific lots of PureFlow B Solution for hemodialysis due to small chamber bursting risk. Contact for remedy details.
NxStage recalls Express Fluid Warmers (FW-300 series) due to potential electrical fire if fluid leaks into power receptacle. No injuries reported but 7 smoke/sparks incidents since 2016.
NxStage recalls specific dialysate sacks due to potential endotoxin levels exceeding safety standards for hemodialysis use. Affected units include SAK-301 to SAK-407 with specific lot numbers and expiration dates.
NxStage recalls premixed dialysate for hemodialysis due to risk of health issues if different fluid formulations are used simultaneously during treatment. The original labeling did not warn against mixing dialysate formulations.
