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.
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 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.
- Affected units
- 2,380
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.
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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