Reported Aug 15, 2018 · Terminated
Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an…
INO therapeutics LLC/dba ikaria
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INO therapeutics LLC/dba ikaria · 1060 Allendale Dr · Port Allen, LA · 70767-3299
Is this the product you have?
- Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage
- Device ClassificationThe 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 INOmeterThe 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
- Lot codes and dates
- Drug Product Lot17FP-0570:
- Serial Numbers
108 of 108 codes
QL15110251QL10110347QL10110129QL14110221QL15030431QL16090656QL10060287QL10110899QL13050382QL14110580QL15030433QL16090682QL11100366QL10110640QL13060172QL14110183QL15030239QL16090726QL10110167QL11100211QL11090274QL14110364QL15040218QL16090216QL11100120QL10101263QL11090302QL14120583QL15030268QL16090578QL08030908QL10070478QL11090309QL14120592QL15030287QL16090742QL10110845QL11090396QL13060801QL15020176QL15030302QL16090839QL10110487QL10111032QL13061068QL14120190QL15030305QL17060229QL10020777QL10110878QL13061305QL14120207QL15110453QL17060244QL10110981QL11090364QL13110288QL14110239QL15110515QL17060339
- Amount recalled
- 108 units
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new INO therapeutics LLC/dba ikaria recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.