The Recall Desk
SevereFDA (Devices)·Z-1454-2023·Announced 2023-05-24

Ventstar Coax breathing circuit connections recalled for loose glued joints

Draeger Medical recalls 2,380 Ventstar Coax breathing circuits due to glued connections that can become loose or detach during 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: FDA Class I medical device recall. The agency's own Class I classification establishes a minimum severity score of 4 per the rubric, applied to critical ventilator components with structural failure potential.

Plain-English summary

Draeger Medical, Inc. is recalling 2,380 units of the Ventstar Coax breathing circuit (model MP03373) distributed nationwide due to structural integrity issues with glued connections.

Glued connections on the breathing circuit can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces. This poses a risk to patients dependent on mechanical ventilation.

All lots of the affected device are identified by UDI-DI 04048675545552. Healthcare facilities and clinicians using this device should discontinue use and contact Draeger Medical for replacement or further instructions.

The recalled product

Product
Ventstar Coax, MP03373
Manufacturer
Draeger Medical, Inc.
Hazard
  • breathing-circuit-detachment
  • connection-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: 04048675545552
  • All lots.

Distribution

Distributed nationwide across the United States.