FDAJuly 9, 2018device

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. Functio...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Terminated

Brands named

ino therapeutics llc dba ikariainoino therapeutics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. Functio... — Recall Details · AllClear