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Terminated

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.

FDA Recall Z-0503-2019 · Posted None

Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2018-10-17
Date Terminated2020-08-26
Product Quantity2189

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

Firm 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).

Root Cause

Packaging process control

Distribution Pattern

US Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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