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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:168747

NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Official recall number

Z-0505-2019

Evidence summary

Product code
KPO
Recall status
Terminated
Event initiated
October 17, 2018
Root cause
Packaging process control
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0505-2019

Field note

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