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Class 2 Device Recall NxStage |
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Date Initiated by Firm |
October 17, 2018 |
Create Date |
November 27, 2018 |
Recall Status1 |
Terminated 3 on August 26, 2020 |
Recall Number |
Z-0502-2019 |
Recall Event ID |
81445 |
510(K)Number |
K053286
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Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
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Product |
NxStage PureFlow B Solution-RFP-402, 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: F1708255, F1709285, F1710323, Q1711861, Q1711863, Q1712021, Q1712022, Q1712023, Q1712033, Q1801345, Q1802399, Q1802400 |
Recalling Firm/ Manufacturer |
NxStage Medical, Inc. 350 Merrimack St Lawrence MA 01843-1748
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For Additional Information Contact |
SAME 978-687-4700
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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
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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 |
21071 |
Distribution |
US Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KPO and Original Applicant = NXSTAGE MEDICAL, INC.
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