INOmeters for INOflo Cylinders Recalled Due to Incorrect Expiration Date Programming
INO therapeutics LLC is recalling 108 INOmeter devices affixed to INOflo cylinders in Japan because they were programmed with an incorrect expiration date.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling/programming error that could lead to the administration of expired drug product, but no injuries or illnesses are reported in the source text.
Plain-English summary
INO therapeutics LLC/dba ikaria is recalling 108 INOmeter devices that were affixed to INOflo DS, NO Gas Control System cylinders in Lot 17FP-0570. These devices are distributed in Japan. The INOmeter is an accessory to the nitric oxide delivery device used to deliver inhaled nitric oxide to patients. It electronically communicates the expiration date of the corresponding cylinder to the delivery device via infrared technology.
The recall is due to a programming error where the INOmeter was programmed with an incorrect expiration date of 11/2017. The label affixed to each INOflo cylinder for Lot 17FP-0570 correctly lists the expiration date as 11/2020. If the device detects an expired date, it registers an error and stops administration after 120 seconds, though healthcare providers can operate the device manually.
Healthcare providers in Japan who have INOmeter devices with the serial numbers listed in the recall notice should stop using them and contact the recalling firm for instructions. The recall involves specific serial numbers associated with Lot 17FP-0570.
The recalled product
- 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…
- Manufacturer
- INO therapeutics LLC/dba ikaria
- Affected units
- 108
Distribution
Distribution scope not specified by the agency.
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