Recall Z-2733-2018 ยท MRN Apparatus, Nitric Oxide Delivery
INO therapeutics LLC/dba ikaria
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. Whe
| Date | Jul 9, 2018 |
| Status | Terminated |
| Reason | 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). |
| Root cause | Process control |
| Action | Mallinckrodt Manufacturing LLC communicated to the Market Authorization Holder, Air Water Inc. of Japan the same day the US Food & Drug Administration was notified on July 09, 2018. However, Air Water Inc. of Japan communicated directly with the Healthcare Providers on July 06, 2018 with no formal letters of notification, known to Mallinckrodt. |
| Quantity | 108 units |
| Distribution | In the country of JAPAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) Ino Therapeutics/Ikaria, Nov 29, 2013 |