Cl ll Zyno Z-800 Volumetric Infusion System

Company:Zyno Medical LLC .
Date of Enforcement Report 4/10/2013
Class ll:

PRODUCT

Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. Recall Number Z-1024-2013

REASON
Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

RECALLING FIRM/MANUFACTURER
Zyno Medical LLC, Natick, MA, on 6/13/2011. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2589 units

DISTRIBUTION
Nationwide

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