The Recall Desk
SevereFDA (Devices)·Z-1451-2023·Announced 2023-05-24

VentStar Coax breathing circuit connections recalled for detachment risk

Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.

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: FDA Class I classification mandates a minimum severity score of 4. The defect involves potential detachment of breathing circuit connections during ventilation, a critical functional failure in life-support equipment that could result in inadequate patient ventilation.

Plain-English summary

Draeger Medical, Inc. is recalling the VentStar Coax (P) 150 ventilation breathing circuit (Model MP00379) due to a defect in the glued connections used in the breathing circuit assembly.

The connections can become loose before or during patient ventilation, which may result in partial or complete detachment of circuit pieces. This failure could compromise the integrity of the breathing circuit and affect proper ventilation delivery.

The recall affects 280 units that have been distributed nationwide in the United States. All lots of the product are included in this recall, identified by UDI-DI 04048675421917.

Healthcare facilities using this equipment should contact Draeger Medical, Inc. immediately to discuss device status, replacement options, and any necessary corrective actions.

The recalled product

Product
VentStar Coax (P) 150, MP00379
Manufacturer
Draeger Medical, Inc.
Hazard
  • circuit-detachment
  • loose-connections
  • ventilation-failure

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: 04048675421917
  • All lots.

Distribution

Distributed nationwide across the United States.