FDA-Drug2018-09-19Class III
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
United Therapeutics Corp.
Hazard
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Sold states
IL, PA
Affected count
2801 devices
Manufactured in
55 Tw Alexander Dr, N/A, Durham, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1188-2018Don't want to check this manually?
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