Events

Recall of Device Recall INOvent, Nitric Oxide Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by INO Therapeutics, Inc..

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
    35892
  • Event Risk Class
    Class 2
  • Event Number
    Z-1410-06
  • Event Initiated Date
    2006-06-29
  • Event Date Posted
    2006-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47097
  • 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
    Nitric Oxide Delivery System - Product Code MRN
  • Reason
    The kel-f tip mounted on the high pressure hose can become dislodge/lodged in the inomax valve outlet.
  • Action
    On June 29, 2006, the firm sent a letter to its consignees advising them to visually verify that the Kel F tip is in place before attempting to connect either of the high pressure hoses to the INOmax cylinders. INO advised that if the tip was not in place, the operator should immediately replace the tip before attaching the hoses. On July 5, 2005, the firm sent a second letter to their consignees with extra Kel F tips and existing instructions from the INOvent Operation & Maintenance Manual outlining the proper replacement procedure for the tips. The firm is following with telephone contact to assure that the letters were delivered to the proper person(s).

Device

Device Recall INOvent, Nitric Oxide Delivery System
  • Model / Serial
    All serial numbers for Model #1605-9000-000
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia
  • Product Description
    INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
  • Manufacturer
    INO Therapeutics, Inc.

Manufacturer

INO Therapeutics, Inc.
  • Manufacturer Address
    INO Therapeutics, Inc., 6 State Route 173, Clinton NJ 08809-1269
  • Source
    USFDA