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U.S. Department of Health and Human Services

Class 3 Device Recall NXStage PureFlow SL SAK303

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  Class 3 Device Recall NXStage PureFlow SL SAK303 see related information
Date Initiated by Firm December 14, 2011
Date Posted January 20, 2012
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-0826-2012
Recall Event ID 60807
510(K)Number K111174  K080919  
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 2		 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 and Original Applicant = NXSTAGE MEDICAL, INC.
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