Medical Device Recall: Vascular Diagnostic Device Air Embolism Risk
Unetixs Vascular is recalling 1706 units of the MultiLab Series II 2CP & 2CP Express vascular diagnostic device due to luer fittings that could allow air lines to be misconnected to intravenous lines, potentially causing 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 recall for a medical device with a design defect creating risk of serious harm (air embolism). No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet occurred, meeting the criteria for Score 3 per the rubric.
Plain-English summary
Unetixs Vascular, Inc., is recalling the MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01, with all serial numbers affected. Approximately 1706 units have been distributed worldwide, including throughout the United States.
The current luer fittings and adaptors on this device create a risk of misconnection between the air line and an intravenous (IV) line. If such a misconnection occurs, air could enter the bloodstream, potentially causing an air embolism—a serious medical emergency.
Healthcare facilities and users of this device should discontinue use immediately and contact Unetixs Vascular, Inc., for corrective measures or device replacement. Patients who may have been treated with the affected device should notify their healthcare provider.
The recalled product
- Product
- MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
- Manufacturer
- Unetixs Vascular, Inc.
- Hazard
- air-embolism
- connection-defect
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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