United Therapeutics Corp. recalls Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.
Recalled September 19, 2018 · FDA recall D-1188-2018 · United Therapeutics
Hazard
Defective Delivery System: Water ingress through the lower water cup sensor of the device. · FDA Class III
Units
2801 devices
Sold at
IL, PA
Description
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
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
Manufacturer(s)
United Therapeutics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →