FDA-Device2023-03-08Class II
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Unetixs Vascular, Inc.
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and Global distribution.
Affected count
984 units
Manufactured in
333 Strawberry Field Rd Ste 11, N/A, Warwick, RI, United States
Products
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1196-2023Don't want to check this manually?
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