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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage

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  Class 2 Device Recall NxStage see related information
Date Initiated by Firm October 17, 2018
Create Date November 27, 2018
Recall Status1 Terminated 3 on August 26, 2020
Recall Number Z-0507-2019
Recall Event ID 81445
510(K)Number K053286  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis

NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Code Information Lot Numbers: F1708258, F1710322, Q1711910, Q1711911, Q1712093, Q1801227, Q1801342, Q1801343, Q1802393, Q1803816
Recalling Firm/
Manufacturer		 NxStage Medical, Inc.
350 Merrimack St
Lawrence MA 01843-1748
For Additional Information Contact SAME
978-687-4700
Manufacturer Reason
for Recall		 PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
FDA Determined
Cause 2		 Packaging process control
Action NxStage initiated a recall on October 17, 2018 via " URGENT MEDICAL DEVICE REMOVAL" Recall Notice to its customers. The notice provided reason for recall, health risk, action to be taken. The customers were instructed to do the following: 1 Check all boxes in your Pureflow B solution inventory, separate them from your other inventory and do not use them. 2. Follow the instructions on the attached reply form or click on the following link to respond electronically, https://www.nxstage.com/rfprecalloct2018, to acknowledge your receipt of this notice. 3. 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 1-866- NXST AGE (1-866-697-8243).
Quantity in Commerce 15880
Distribution US 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 = KPO and Original Applicant = NXSTAGE MEDICAL, INC.
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