Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System
Medical device recall Z-2733-2018. Published in FDA’s Enforcement Report on Aug 15, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 15, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 108 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
108 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Drug Product Lot: 17FP-0570: Serial Numbers: QL15110251 QL10110347 QL10110129 QL14110221 QL15030431 QL16090656 QL10060287 QL10110899 QL13050382 QL14110580 QL15030433 QL16090682 QL11100366 QL10110640 QL13060172 QL14110183 QL15030239…
Every code shown here, 1,232 characters
Drug Product Lot: 17FP-0570: Serial Numbers: QL15110251 QL10110347 QL10110129 QL14110221 QL15030431 QL16090656 QL10060287 QL10110899 QL13050382 QL14110580 QL15030433 QL16090682 QL11100366 QL10110640 QL13060172 QL14110183 QL15030239 QL16090726 QL10110167 QL11100211 QL11090274 QL14110364 QL15040218 QL16090216 QL11100120 QL10101263 QL11090302 QL14120583 QL15030268 QL16090578 QL08030908 QL10070478 QL11090309 QL14120592 QL15030287 QL16090742 QL10110845 QL11090396 QL13060801 QL15020176 QL15030302 QL16090839 QL10110487 QL10111032 QL13061068 QL14120190 QL15030305 QL17060229 QL10020777 QL10110878 QL13061305 QL14120207 QL15110453 QL17060244 QL10110981 QL11090364 QL13110288 QL14110239 QL15110515 QL17060339 QL10070487 QL11090353 QL13110607 QL14110273 QL15110565 QL17060408 QL10100716 QL04100498 QL14050878 QL14110348 QL15110566 QL17060433 QL10101152 QL10070427 QL14060106 QL15010810 QL16090250 QL17060447 QL10060228 QL10110293 QL14060244 QL15010831 QL16090265 QL17060453 QL08031575 QL10060326 QL10110842 QL15011726 QL16090266 QL17060522 QL10070686 QL10110319 QL13110100 QL15010742 QL16090439 QL17060525 QL10060315 QL10110682 QL14110251 QL15030223 QL16090650 QL17090297 QL10111117 QL13050250 QL14110539 QL15030248 QL16090654 QL17090334
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
In the country of JAPAN
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 9, 2018.
- FDA classified it on Aug 8, 2018.
- FDA’s Enforcement Report published it on Aug 15, 2018.
- FDA terminated it on Nov 30, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- INO therapeutics LLC/dba ikaria, of Port Allen, LA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.