FDA Medical Device Recalls (openFDA)
NxStage Medical, Inc.: 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.
- Recall number
- Z-1707-2019
- Recalling firm
- NxStage Medical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2019-04-11
- Posted
- not on file
- Terminated
- 2020-06-08
- Reason
- Certain lots were mislabeled with incorrect product number.
- Root cause
- 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
- 3,940 units
- Distribution
- US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
- Lot, serial or model codes
- Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020
- 510(k) numbers
- ["K053286"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3003464075
- Firm city
- Lawrence
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28