NxStage Medical Inc: Device Recall

Recall #Z-2160-2024 · 05/14/2024

Class II: Risk

Recall Details

Recall Number: Z-2160-2024
Classification: Class II
Product Type: Device
Recalling Firm: NxStage Medical Inc
Status: Ongoing
Date Initiated: 05/14/2024
Location: Lawrence, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1316936 units

Reason for Recall

The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.

Product Description

NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456

Distribution Pattern

US Nationwide distribution.

Other Recalls by NxStage Medical Inc

Class II: Risk 04/28/2025

Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.

View all recalls by NxStage Medical Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.