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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage PureFlow B Solution

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  Class 2 Device Recall NxStage PureFlow B Solution see related information
Date Initiated by Firm April 11, 2019
Create Date June 02, 2019
Recall Status1 Terminated 3 on June 08, 2020
Recall Number Z-1707-2019
Recall Event ID 82693
510(K)Number K053286  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NxStage PureFlow B Solution, REF RFP-401, M535RPF4010

NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Code Information Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020
Recalling Firm/
Manufacturer		 NxStage Medical, Inc.
350 Merrimack St
Lawrence MA 01843-1748
For Additional Information Contact
978-687-4700
Manufacturer Reason
for Recall		 Certain lots were mislabeled with incorrect product number.
FDA Determined
Cause 2		 Labeling mix-ups
Action On April 11, 2019, NxStage Medical Inc. issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Customers were advised to take the following actions: 1. Check all boxes in your Pureflow B solution inventory. If you find any boxes or individual bags of Pureflow B solution from the affected lots listed in the table below, separate them from your other inventory and do not use them. Refer to Appendix A for pictures to assist in locating part or SKU and lot number of your Pureflow B solution inventory. 2. Promptly complete and return the online response form at the link www.novasyte.com/nxstageapr2019 to acknowledge your receipt of this notice, even if you do not have the affected product on hand. 3. Upon completion of the online response form, your facility will be scheduled for a product return pick up date based on the availability you provide. NxStage is partnered with Novasyte to assist in this action. Novasyte specializes in providing outsourced commercial service teams and technologies for the medical device industry. For any assistance regarding this action please contact Novasyte using the information below: Phone: (760) 205-3020 Email: nxstageapr2019@novasyte.com
Quantity in Commerce 3,940 units
Distribution US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
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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