Recall Z-1194-2023— Unetixs Vascular, Inc.

Name: FDA recall Z-1194-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-10

Class II · Ongoing

Class II FDA medical device recall by Unetixs Vascular, Inc., initiated 2023-02-10. It names one FDA 510(k) clearance: K904392. Product: MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01. Reason: 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..

Recalling firm: Unetixs Vascular, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-10
Firm location: Warwick, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K904392 — MULTILAB 2000Unetixs, Inc.·cleared 1991-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.