FDA-Drug2014-07-16Class II
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
United Therapeutics Corp.
Hazard
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Sold states
Fl, TX.
Affected count
188 Units
Manufactured in
55 Tw Alexander Dr, P.O. Box 14186, Research Triangle Park, NC, United States
Products
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1423-2014Don't want to check this manually?
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