Product: Tyvaso Inhalation System Patient  a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099  RX Only.  Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709
Reason for recall: Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Recall initiated: 20180814
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated