Unetixs Vascular, Inc. FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01Class IIFeb 10, 2023The current luer fittings and adaptors allow for the possibi	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intr	Class IIDevices	Feb 10, 2023
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01Class IIFeb 10, 2023The current luer fittings and adaptors allow for the possibi	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intr	Class IIDevices	Feb 10, 2023
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01Class IIFeb 10, 2023The current luer fittings and adaptors allow for the possibi	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intr	Class IIDevices	Feb 10, 2023
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01Class IIFeb 10, 2023The current luer fittings and adaptors allow for the possibi	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intr	Class IIDevices	Feb 10, 2023