Unetixs Vascular, Inc. recalls MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
- Recall date
- February 10, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1194-2023
- FDA classification
- Class II
- Brand / firm
- Unetixs Vascular, Inc.
- Sold / distributed
- Worldwide distribution - US Nationwide and Global distribution.
Why it was recalled
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
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