Mallinckrodt Pharmaceuticals INOflo DS — Class II medical device recall Z-2733-2018
Terminated recall by INO therapeutics LLC/dba ikaria, reported 2018-08-15. INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (
| Recall number | Z-2733-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | INO therapeutics LLC/dba ikaria, Port Allen, LA, United States |
| Recall initiated | 2018-07-09 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2020-11-30 |
| Countries outside the US | JP |
| Quantity | 108 units |
| Reason classes | labeling |
| Lot numbers | 17FP-0570 |
| Serial numbers | QL04100498, QL08030908, QL08031575, QL10020777, QL10060228, QL10060287, QL10060315, QL10060326, QL10070427, QL10070478, QL10070487, QL10070686, QL10100716, QL10101152, QL10101263, QL10110129, QL10110167, QL10110293, QL10110319, QL10110347, QL10110487, QL10110640, QL10110682, QL10110842, QL10110845 and 83 more |
Product
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.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2733-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.