Z-1196-2023 Class II Ongoing

Recalled by Unetixs Vascular, Inc. — Warwick, RI

Recall Details

Product Type
Devices
Report Date
March 8, 2023
Initiation Date
February 10, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
984 units

Product Description

MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

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 Pattern

Worldwide distribution - US Nationwide and Global distribution.

Code Information

All Serial Numbers