Company:.NxStage Medical, Inc.
Date of Enforcement Report 12/2/2015
Class lI:
PRODUCT
NxStage System One S Cycler – Model no. NX1000-3-A. For home hemodialysis.
Recall Number Z-0336-2016
REASON
Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
RECALLING FIRM/MANUFACTURER
NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
133 units
DISTRIBUTION
Nationwide and Internationally
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