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U.S. Department of Health and Human Services

Class 2 Device Recall Subsystem, proportioning

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  Class 2 Device Recall Subsystem, proportioning see related information
Date Initiated by Firm January 29, 2018
Create Date March 01, 2018
Recall Status1 Terminated 3 on April 03, 2020
Recall Number Z-0811-2018
Recall Event ID 79185
510(K)Number K140571  
Product Classification Subsystem, proportioning - Product Code FKR
Product NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070

Hemodialysis systems and accessories
Code Information SAK-301- Lot # 70879245, Exp Date 7/11/2019 SAK-302- Lot # 71079056, Exp Date 7/30/2019 SAK-303- Lot #'s 70879181 & 70879224,  SAK-304- Lot #'s 70779236, 70879045, 70879105, 70879220 & 70979066, Exp Date 7/8/2019 SAK-306- Lot # 70979110, Exp Date 7/24/2019 SAK-307- Lot #'s 70879187 & 71079144, Exp Date 8/27/2019 SAK-402- Lot # 70879235, Exp Date 7/11/2019 SAK-405- Lot #'s 70779202 & 70879233, Exp Date 7/9/2019 SAK-406- Lot #'s 70979253, Exp Date 7/29/2019 SAK-407- Lot #'s 70879236 , Exp Date 7/11/2019
Recalling Firm/
NxStage Medical, Inc.
350 Merrimack Street
Lawrence MA 01843-1748
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
FDA Determined
Cause 2
Material/Component Contamination
Action On January 29, 2018 Product Recall Notices & Recall Reply Forms included were emailed to those patients for whom the firm had an email address. Hard copy letters were sent via UPS second day air to patients for whom NxStage did not have an email address. All Dialysis centers were contacted via email. In addition to the active patients and dialysis center consignees of affected product, recall letters were also emailed to the Dialysis Center Home Training Nurse Manager for all active or dropped patients who were shipped affected product, and corporate contacts for national dialysis accounts. Customers are advised to inspect inventory, quarantine, discontinue use and return product. Customers are also encouraged to return the completed Recall Reply Form. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. Customers with questions may call Customer Service at 1-866-697-8243.
Quantity in Commerce 16,039 cases/2 units
Distribution Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain
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.