Mallinckrodt Manufacturing LLC
Madison, WI, US
Mallinckrodt Manufacturing LLC appears in FDA device records in Madison, WI. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Mallinckrodt Manufacturing LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- INO Therapeutics (dba Ikaria)enforcement report, recall
- Ino Therapeutics, LLC510(k), recall
- Ino Therapeutics, LLC/Dba Ikaria510(k), enforcement report, recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Mallinckrodt Manufacturing LLC between 2005 and 2025. The busiest year on record is 2012, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 1 |
| 2020 | 1 |
| 2023 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242578 | EVOLVE Nitric Oxide Delivery System | MRN | Substantially Equivalent | |
| K222930 | Evolve Nitric Oxide Delivery System | MRN | Substantially Equivalent | |
| K211153 | Inomax DSIR | MRN | Substantially Equivalent | |
| K200389 | INOmax DSIR Plus | MRN | Substantially Equivalent | |
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | MRN | Substantially Equivalent | |
| K122689 | INOBLENDER | MRO | Substantially Equivalent | |
| K121021 | INOMAX DS (DELIVERY SYSTEM) | MRN | Substantially Equivalent | |
| K113272 | INOMAX DS(DELIVERY SYSTEMS | MRN | Substantially Equivalent | |
| K110344 | INOMAX DSIR (DELIVERY SYSTEM) | MRN | Substantially Equivalent | |
| K110635 | INOMAX DS(IR) (DELIVERY SYSTEM) | MRN | Substantially Equivalent | |
| K093922 | INOMAX DS | MRN | Substantially Equivalent | |
| K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | |
| K090958 | INOMAX DS (DELIVERY SYSTEM) | MNR | Substantially Equivalent | |
| K081691 | INOMAX DS (DELIVERY SYSTEM) | MRN | Substantially Equivalent | |
| K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | |
| K071516 | INOMAX DS | MRN | Substantially Equivalent | |
| K070867 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | |
| K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | Substantially Equivalent | |
| K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 | MRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004531588 | 3004531588 | Mallinckrodt Manufacturing LLC | 6603 Femrite Dr, MADISON, WI 53718 US | 2026 | |
| 3009352626 | 2350054 | Mallinckrodt Manufacturing LLC | 1060 Allendale Dr, Port Allen, LA 70767 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MRPAnalyzer, Nitric Oxide
- MRQAnalyzer, Nitrogen Dioxide
- MRNApparatus, Nitric Oxide Delivery
- MROApparatus, Nitric Oxide, Backup Delivery
- MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The Counter
- BXKGas, Calibration (Specified Concentration)
- BZOSet, Tubing And Support, Ventilator (W Harness)
- IYTSystem, Rebreathing, Radionuclide
- BYXTubing, Pressure And Accessories
- MNRVentilatory Effort Recorder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2450-2023 | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators. | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. | Class I | Open, Classified | |
| Z-2733-2018 | Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device. The amount of time that gas flow administered to a patient is captured in the INOmeter. Each INOmeter is programmed to include the drug product expiration date as listed on the INOflo drug product label. The INOmeter electronically communicates to the nitric oxide delivery device via infrared technology by way of the iButton and in so communicates the expiration date of the corresponding cylinder of INOflo drug product to the delivery device. The delivery device evaluates and compares the expiration date to the current date of therapy administration. If the drug product expiration date is prior to the current date, an error and alarm is registered by the nitric oxide delivery device and administration of the expired drug to the patient is stopped after 120 seconds. If this occurs, the healthcare provider can operate the nitric oxide delivery device manually and deliver the INOflo as indicated in the Instructions For Use (IFU). The INOflo delivery device has the functionality to administer INOflo in manual mode. | 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). | Class II | Terminated | |
| Z-1076-2017 | 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. | 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. | Class II | Terminated | |
| Z-1223-2015 | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. | 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. | Class II | Terminated | |
| Z-2687-2017 | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery. | Product was improperly labeled leading to improper storage. | Class II | Terminated | |
| Z-0575-2015 | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates. | 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. | Class II | Terminated | |
| Z-1528-2014 | 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. | 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 | Class II | Terminated | |
| Z-0583-2012 | INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. | Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10. | Terminated | ||
| Z-1410-06 | INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000 | The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain