Events

Recall of Device Recall INOmax DSIR Delivery System

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

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
    67947
  • Event Risk Class
    Class 2
  • Event Number
    Z-1528-2014
  • Event Initiated Date
    2014-03-27
  • Event Date Posted
    2014-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126644
  • 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
    Apparatus, nitric oxide delivery - Product Code MRN
  • Reason
    An anomaly impacts the monitoring system of inomax dsir plus (software 3.0.0). when the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended no cell failure alarm will occur. in addition, an unintended no2 cell failure alarm may also occur. the no/no2 cell failure alarms are caused by an average no/no2 circuit concentration greater tha.
  • Action
    Ikaria sent an Urgent Field Corrective Action letter via FedEx on March 27, 2014. The letter identified the issue, and requested that all INOmax DSIR with software version 3.0.0 be returned to Ikaria. Customers with questions were instructed to contact Ikaria Customer Care at 1-877-566-9466. For questions regarding this recall call 877-566-9466.

Device

Device Recall INOmax DSIR Delivery System
  • Model / Serial
    Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420,  DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including DC and VA.
  • Product Description
    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
  • Manufacturer
    INO Therapeutics (dba Ikaria)

Manufacturer

INO Therapeutics (dba Ikaria)
  • Manufacturer Address
    INO Therapeutics (dba Ikaria), 2902 Dairy Dr, Madison WI 53718-3809
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    USFDA