Company:.NxStage Medical, Inc.
Date of Enforcement Report 12/2/2015
Class lI:
PRODUCT
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 Recall Number Z-0326-2016
REASON
Ultrafiltration (UF) Volume software error inaccurate fluid removal
RECALLING FIRM/MANUFACTURER
NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
323
DISTRIBUTION
Nationwide and Internationally
___________________________________