Home / Recalls / United Therapeutics Corp. / D-1188-2018

D-1188-2018 Class III Terminated

Recalled by United Therapeutics Corp. — Durham, NC

Recall Details

Product Type: Drugs
Report Date: September 19, 2018
Initiation Date: August 14, 2018
Termination Date: October 30, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2801 devices

Product Description

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

Reason for Recall

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

Distribution Pattern

IL, PA

Code Information

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