Class 3 Device Recall NXStage PureFlow SL SAK303

• Date Initiated by Firm: December 14, 2011
• Date Posted: January 20, 2012
• Recall Status: Terminated on April 17, 2012
• Recall Number: Z-0826-2012
• Recall Event ID: 60807
• 510(K)Number: K080919 K111174
• Product Classification: Subsystem, proportioning - Product Code FKR
• Product: NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
• Code Information: Lot 1117911, Exp. 2013-09
• Recalling Firm/ Manufacturer: NxStage Medical, Inc.; 439 S Union St Fl 5th; Lawrence MA 01843-2837
• For Additional Information Contact: 978-687-4700
• Manufacturer Reason for Recall: Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System
• FDA Determined Cause: Employee error
• Action: On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an "IMPORTANT MEDICAL DEVICE RECALL" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and complete and return the DEVICE PRODUCT RECALL REPLY FORM even if they do not have any of the affected product on hand via postage-prepaid envelop provided. If you have any questions about this notice, contact NxStage Customer Support at 866-Nxstage ( 697-8243).
• Quantity in Commerce: 1,192 devices
• Distribution: Nationwide distribution.
• 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 = FKR