FDA recall Z-2160-2024

NxStage Medical Inc · Class II · device

Product

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

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-05-14
Report date
2024-06-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lawrence, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2024