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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage Dialysate Sack (SAK) with Concentrate

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  Class 2 Device Recall NxStage Dialysate Sack (SAK) with Concentrate see related information
Date Initiated by Firm May 14, 2014
Date Posted June 24, 2014
Recall Status1 Open3, Classified
Recall Number Z-1857-2014
Recall Event ID 68354
510(K)Number K111174  K140571  
Product Classification Dialysate Subsystem, proportioning - Product Code FKR
Product NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-304
Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) 60

The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.


Code Information Lot code:, 40179091, 40179069, 40179068, 40179029, 40179019, 31279094, 3067901, 3057932, 3057919, 3057918, 3057909, 3057908
Recalling Firm/
Manufacturer
NxStage Medical, Inc.
350 Merrimack Street
Lawrence MA 01843-1748
For Additional Information Contact
978-687-4700
Manufacturer Reason
for Recall
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
FDA Determined
Cause 2
Material/Component Contamination
Action NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. 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 16,625 cases
Distribution Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FKR and Original Applicant = NXSTAGE MEDICAL, INC.
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