The Recall Desk
CriticalFDA (Devices)·Z-1447-2023·Announced 2023-05-24

Draeger VentStar Anesthesia Breathing Circuit Connections May Detach

Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I medical device recall. Class I classification indicates a reasonable probability of serious adverse health consequences or death if the product is used.

Plain-English summary

Draeger Medical, Inc. is recalling the VentStar Anesthesia (N) 180 breathing circuit due to a defect with glued connections. These connections can become loose before or during ventilation, which may result in partial or complete detachment of circuit pieces.

The affected VentStar Anesthesia (N) 180 devices have been distributed nationwide throughout the United States. All lots of this device are included in this Class I recall.

Healthcare facilities that have received this device should take appropriate action based on guidance from Draeger Medical, Inc. and the U.S. Food and Drug Administration.

The recalled product

Product
VentStar Anesthesia (N) 180, MP00333
Manufacturer
Draeger Medical, Inc.
Hazard
  • circuit-disconnection

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 (2)

  • UDI-DI: 04048675422198
  • All lots.

Distribution

Distributed nationwide across the United States.