Recall of Device Recall Zyno Z800 Volumetric Infusion System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zyno Medical LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, insulin bolus - Product Code OPP
  • Reason
    Update instruction for use for preventative maintenance (pm) schedule and addition of odometer software to monitor accumulative fluid volume infused by the pump.
  • Action
    Zyno Medical initiated recall 6/13/11 to accounts advising of a Preventative Maintenance (PM) Schedule and a software upgrade Odometer to monitor counts of accumulative fluid volume infused by the unit. On 3/1/13, firm issued correction notice to users that have not had the software implemented on their unit. Units will be serviced at their scheduled PM. The notice identified the product, problem, and actions to be taken by the customers.


  • Model / Serial
    LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution.
  • Product Description
    Z-800 Volumetric Infusion System. || For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
  • Manufacturer


  • Manufacturer Address
    Zyno Medical LLC, 10 Tech Circle, Natick MA 01760
  • Manufacturer Parent Company (2017)
  • Source