United Therapeutics Corp.: 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 Replac

Is my product affected?

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 27

• Brand TYVASO

Check against the official notice below — it lists the full affected range.

What happened

United Therapeutics Corp. is recalling 2,801 Tyvaso Inhalation System devices distributed in Illinois and Pennsylvania. The devices have a defective delivery system that allows water to enter through the lower water cup sensor. The affected products include Tyvaso Starter Kits and TD-300/A Replacement devices with specific lot numbers and expiration dates ranging from July 2019 to July 2021.

The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

Details from the source

Reason for recall: Defective Delivery System: Water ingress through the lower water cup sensor of the device. Distribution: IL, PA Quantity: 2801 devices Lot/code info: Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b) Lot # 2101504, EXP 4/24/2021; 2101509, 2101522, EXP 5/8/2021; 2101531, EXP 5/15/2021; 2101534, EXP 6/10/2021; 2101543, EXP 6/14/2021; 2101558, EXP 7/26/2021

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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