Vascular diagnostic devices recalled due to air embolism misconnection risk
Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 recall with no reported illnesses or injuries. The hazard—air embolism from device misconnection—poses real risk of serious harm, but falls under the rubric category of 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Unetixs Vascular, Inc. is recalling the MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device (Model Number 11949-0000-01). A total of 2,310 units have been distributed worldwide, including throughout the United States.
The device contains luer fittings and adaptors that create a connection hazard. Specifically, the air line can be misconnected to an intravenous (IV) line. If this misconnection occurs, it may cause an air embolism—a potentially serious condition where air enters the bloodstream.
Healthcare facilities using this device should immediately stop using it and contact Unetixs Vascular for instructions regarding return or replacement. Any adverse events associated with this device should be reported to the FDA.
The recalled product
- Product
- MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
- Manufacturer
- Unetixs Vascular, Inc.
- Affected units
- 2,310
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.
Part of a larger recall action
This product is one of 4 recalled by Unetixs Vascular, 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Unetixs Vascular, Inc.
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- HighVascular Diagnostic Device Recalled for Risk of Air Line Misconnection
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- HighVascular diagnostic device recalled for air line misconnection risk
FDA (Devices) · 2023-03-08
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