Unetixs Vascular, Inc. recalls MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

Recall date

February 10, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1193-2023

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 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01