FDAClass IIDecember 5, 2018

NxStage PureFlow B Solution-RFP-RFP-454 recall

NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement…

Why was NxStage PureFlow B Solution-RFP-RFP-454 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: Q1801222, Q1801341, Q1802396, Q1802397

Product
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement…
Recalling firm
NxStage Medical, Inc.
Quantity
7275
Distribution
US Nationwide Distribution.
Recall date
December 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls