The Recall Desk
SevereFDA (Devices)·Z-1177-2021·Announced 2021-03-17

Draeger VentStar Anesthesia Breathing Circuits Recalled for Detachment Risk

Draeger Medical is recalling VentStar Anesthesia breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure of a critical life-support component (ventilation) that can hinder patient ventilation, which aligns with the rubric criteria for Severe severity involving significant injury risk or structural defects in medical devices.

Plain-English summary

Draeger Medical, Inc. is recalling VentStar Anesthesia (N) 180 breathing circuits, order number MP00333. These products are intended for single use to conduct respiratory gases between an anesthesia machine or ventilator and a patient.

The recall is due to a defect where the Y-piece may become detached from the ventilation hose either before or during the ventilation process. This detachment causes a leak that can hinder the ventilation of the patient.

The recall covers 4,450 units distributed nationwide in the United States. All lots are affected. Healthcare providers should stop using these breathing circuits and contact Draeger Medical for further instructions.

The recalled product

Product
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →