The Recall Desk
HighFDA (Devices)·Z-1179-2021·Announced 2021-03-17

Draeger VentStar Watertrap Breathing Circuits Recalled for Detachment Risk

Draeger Medical is recalling 150 units of VentStar Watertrap (N) 180 breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Draeger Medical, Inc. is recalling 150 units of VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets (Order Number: MP00363). These products are intended for single use to conduct respiratory gases between an anesthesia machine or ventilator and a patient. The recall covers all lots and was distributed nationwide in the United States.

The recall was initiated because 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 source text does not report any specific injuries or illnesses associated with this defect.

Healthcare facilities and users should stop using the affected breathing circuits immediately. Draeger Medical, Inc. is the recalling firm responsible for managing this Class II recall.

The recalled product

Product
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Affected units
150

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 →