Apr

2013

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll Zyno Z-800 Volumetric Infusion System

Amy Sellers

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