Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation recall — FDA D-1188-2018
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Overview of recall records associated with United Therapeutics Corp., including dates, categories and classifications where available.
Classification mix: Class III: 1, Class II: 1.
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
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…
This page summarizes recall records in which the official source identifies United Therapeutics Corp. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.