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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80834

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 14, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
United Therapeutics Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1188-2018
Recall number
D-1188-2018
Initiated
August 14, 2018
Classification
Class III
Status
Terminated
Recalling firm
United Therapeutics Corp.
Quantity
2801 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Water ingress through the lower water cup sensor of the device.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

IL, PA