Class 2 Device Recall NxStage PureFlowB Solution

• Date Initiated by Firm: January 24, 2014
• Date Posted: February 24, 2014
• Recall Status: Terminated on August 29, 2014
• Recall Number: Z-1073-2014
• Recall Event ID: 67405
• 510(K)Number: K053286
• Product Classification: Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
• Product: NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
• Code Information: Lot Number: F113662
• Recalling Firm/ Manufacturer: NxStage Medical, Inc.; 350 Merrimack Street; Lawrence MA 01843-1748
• For Additional Information Contact: 866-697-8243
• Manufacturer Reason for Recall: Mislabeled product.
• FDA Determined Cause: Packaging process control
• Action: NxStage sent a Voluntary Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to check all boxes in inventory for the recalled lot and segregate and quarantine them. In addition, they were asked to complete the recall reply form and return it by fax to NxStage Medical as well as to contact NxStage Customer service to arrange for return of all affected product and for replacement to be sent. Distributor was asked to notify all downstream customers and to provide NxStage Medical with a list of customers. Please complete and fax this form to 978-687-4810 even if you do not have any of the affected product on hand. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866- NXSTAGE (1-866-697-8243).
• Quantity in Commerce: 969 cases (2 bags per case)
• Distribution: US Distribution including the states of NY, TX, ID, AR, CA and AL
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPO