Class III
Terminated
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
- Company
- United Therapeutics Corp.
- Recall Initiated
- August 14, 2018
- Posted
- September 19, 2018
- Recall Number
- D-1188-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2801 devices
- Firm Location
- Durham, NC, United States
Reason for Recall
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Distribution
IL, PA
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
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