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
Reported: September 19, 2018 Initiated: August 14, 2018 #D-1188-2018
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.
Details
- Recalling Firm
- United Therapeutics Corp.
- Units Affected
- 2801 devices
- Distribution
- IL, PA
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by United Therapeutics Corp.. Units affected: 2801 devices.
Why was this product recalled? ▼
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 19, 2018. Severity: Low. Recall number: D-1188-2018.
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