FDA (Devices) recall action 81445

NxStage Medical, Inc. recalled 8 products on 2018-12-05

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2018-12-05
Critical: 0
Units: 423,353

Why these products were recalled

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

SevereFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard
NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Product
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Distribution
0 states
SevereFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk
NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled Due to Bag Burst Risk
NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Distribution
0 states
SevereFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury
NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Product
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Distribution
0 states
SevereFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting
NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Burst Injury Risk
NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Product
NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting
NxStage Medical is recalling 59,100 units of PureFlow B Solution because the smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-05
NxStage PureFlow B Solution Recalled Due to Bag Burst Risk
NxStage Medical is recalling 2,189 units of PureFlow B Solution because the bag's smaller chamber can burst, releasing electrolyte fluid that may injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Distribution
0 states