Product Description NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Recall Number Z-1214-2013

Classification Class II

Code Info F023444

Product Distributed Qty 1480 cases (2 bags per case)

Reason For Recall Product may be mislabeled.

Event Id 64820

Product Type Devices

Status Ongoing

Recalling Firm NxStage Medical, Inc., Lawrence, MA, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-18

Initial Firm Notification of Consignee or Public E-Mail

Distribution Pattern Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.