FDA recall Z-1864-2025

Product

NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2025-04-28

Report date

2025-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1864-2025