FDA recall Z-1194-2023

Unetixs Vascular, Inc. · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide and Global distribution.

Key facts

Status: Ongoing
Initiation date: 2023-02-10
Report date: 2023-03-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warwick, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1194-2023