Events

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
    Recall
  • Event ID
    64448
  • Event Risk Class
    Class 2
  • Event Number
    Z-1024-2013
  • Event Initiated Date
    2011-06-13
  • Event Date Posted
    2013-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116161
  • 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.

Device

Device Recall Zyno Z800 Volumetric Infusion System
  • 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
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
    Zyno Medical LLC

Manufacturer

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