FDA Medical Device Recalls (openFDA)
NxStage Medical, Inc.: NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
- Recall number
- Z-0503-2019
- Recalling firm
- NxStage Medical, Inc.
- Product
- NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
- Status
- Terminated
- Initiated
- 2018-10-17
- Posted
- not on file
- Terminated
- 2020-08-26
- Reason
- 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
- Root cause
- 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
- 2189
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Lot Numbers: Q1802398, Q1802428
- 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