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INO therapeutics LLC/dba ikaria Recalls

1 recall on record · August 15, 2018 to August 15, 2018 · Medical Devices

August 15, 2018Medical DevicesFDA

INO therapeutics LLC/dba ikaria recalls Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmete

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).

INO therapeutics LLC/dba ikaria Recalls | RecallWatchUSA