NxStage Medical Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFClass IIApr 28, 2025Potential for the perimeter seal on the small chamber of the	Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte f	Class IIDevices	Apr 28, 2025
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-Class IIMay 14, 2024The smaller chamber of the two chamber bag is bursting when	The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prio	Class IIDevices	May 14, 2024