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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 280
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.
Part of a larger recall action
This product is one of 22 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.
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