The Recall Desk
ModerateFDA (Drugs)·D-1188-2018·Announced 2018-09-19

United Therapeutics Recalls Tyvaso Inhalation Systems Due to Water Ingress

United Therapeutics is recalling Tyvaso inhalation systems because water can enter the device through the lower water cup sensor.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the violation is not likely to cause adverse health consequences. The defect involves water ingress, which is a functional issue rather than a direct toxicological hazard.

Plain-English summary

United Therapeutics Corporation is recalling 2,801 Tyvaso (treprostinil) Inhalation System Patient Starter Kits and TD-300/A Replacement Device Kits. The recall is due to a defect where water can enter the device through the lower water cup sensor.

The affected products are prescription drugs used for pulmonary arterial hypertension. The recall covers specific lots with expiration dates ranging from July 2019 to July 2021. The devices were distributed in Illinois and Pennsylvania.

Patients using these devices should contact their healthcare provider or United Therapeutics for further instructions on how to proceed with their treatment.

The recalled product

Product
TYVASO (TREPROSTINIL)
Brand
TYVASO
Manufacturer
United Therapeutics Corp.
Category
Drug — Inhalation Device
Hazard
Affected units
2,801

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distributed in 2 states:

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