Events

Recall of Device Recall INOmax DSIR Plus 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
    75878
  • Event Risk Class
    Class 2
  • Event Number
    Z-1076-2017
  • Event Initiated Date
    2016-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151520
  • 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
    Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.
  • Action
    Recall letter was sent to customers in a e-mail beginning November 21, 2016 with a had copy sent via FedEx overnight with signature receipt beginning December 5, 2016. Devices will be picked up and replaced by Mallinckrodt. Questions can be directed to 1-877-KNOW-INO (1-877-566-9466).

Device

Device Recall INOmax DSIR Plus delivery system
  • Model / Serial
    Serial Numbers: DS20070030, DS20070043, DS20070094, DS20070268, DS20090096, DS20090458, DS20090484, DS20090539, DS20090620, DS20090645, DS20100071, DS20100118, DS20100216, DS20100266, DS20100268, DS20100330, DS20100439, DS20100496, DS20100604, DS20100675, DS20100744, DS20100762, DS20100950, DS20101199, DS20101337, DS20101359, DS20101369, DS20101406, DS20101443, DS20101524, DS20110242, DS20110480, DS20110577, DS20110849, DS20110868, DS20110912, DS20110915, DS20110972, DS20110976, DS20110990, DS20120008, DS20120161, DS20120266, DS20120281, DS20120370.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, and TX
  • Product Description
    Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). || The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
  • Manufacturer
    INO Therapeutics (dba Ikaria)

Manufacturer

INO Therapeutics (dba Ikaria)
  • Manufacturer Address
    INO Therapeutics (dba Ikaria), 6603 Femrite Dr, Madison WI 53718-6801
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    USFDA