FDA recall Z-1195-2023

Product

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

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-1195-2023