Ino Therapeutics, LLC/Dba Ikaria
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Ino Therapeutics, LLC/Dba Ikaria makes
Ino Therapeutics, LLC produces the INOMAX DS delivery system, a device designed for the administration of inhaled nitric oxide in clinical settings.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Inomax Ds(Ir) (Delivery System) Ref K110635
Regimes: 510(k) Registry: 510(k)Inomax Ds(Delivery Systems Ref K113272
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Ino Therapeutics, LLC/Dba Ikaria, the earliest on 2014-03-27 and the most recent on 2018-07-09. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 9 Jul 2018 Z-2733-2018 Class II Terminated INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinder has the correct expiration date noted (11/2020).
2016
- 21 Nov 2016 Z-1076-2017 Class II Terminated 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.
2015
- 14 Jan 2015 Z-1223-2015 Class II Terminated Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.
2014
- 17 Oct 2014 Z-0575-2015 Class II Terminated An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.
- 27 Mar 2014 Z-1528-2014 Class II Terminated 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
Frequently asked questions
How many devices does Ino Therapeutics, LLC/Dba Ikaria have in the registry?
The registry currently lists 2 devices for Ino Therapeutics, LLC/Dba Ikaria. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ino Therapeutics, LLC/Dba Ikaria's devices?
Among its 2 most recently registered devices, Ino Therapeutics, LLC/Dba Ikaria has devices listed in FDA 510(k) (2 devices).
What risk classes do Ino Therapeutics, LLC/Dba Ikaria's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ino Therapeutics, LLC/Dba Ikaria's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ino Therapeutics, LLC/Dba Ikaria?
FDA recall records list 5 recalls initiated by Ino Therapeutics, LLC/Dba Ikaria, the most recent initiated on 9 Jul 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ino Therapeutics, LLC/Dba Ikaria in the registry?
The most recently registered devices listed for Ino Therapeutics, LLC/Dba Ikaria include INOMAX DS(IR) (DELIVERY SYSTEM) and INOMAX DS(DELIVERY SYSTEMS.