Vascular diagnostic device recalled for air line misconnection risk
Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall involving a design flaw that creates a serious risk of air embolism—a potentially fatal condition—if the air and IV lines are misconnected. No injuries or illnesses have been reported, placing this at severity level 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Unetixs Vascular, Inc. is recalling the MultiLab Series II REVO non-invasive vascular diagnostic device (Model 12950-0000-01) due to a connector design flaw. All 984 units with all serial numbers are affected.
The device uses luer fittings and adaptors that can allow the air line to be misconnected to an intravenous (IV) line. This misconnection could result in an air embolism, a potentially life-threatening condition where air enters the bloodstream.
The device was distributed worldwide, including throughout the United States, for use in medical facilities and clinical settings.
If you use or have access to this device, do not use it. Contact Unetixs Vascular, Inc. immediately for instructions on returning or disposing of the device. Consult with your healthcare provider or facility for alternative diagnostic equipment.
The recalled product
- Product
- MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
- Manufacturer
- Unetixs Vascular, Inc.
- Hazard
- air-embolism
- misconnection
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 (1)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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