PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 8, 2023 Initiated: February 10, 2023 #Z-1193-2023

Product Description

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

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.

Details

Recalling Firm
Unetixs Vascular, Inc.
Units Affected
1706 units
Distribution
Worldwide distribution - US Nationwide and Global distribution.
Location
Warwick, RI

Frequently Asked Questions

What product was recalled?
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01. Recalled by Unetixs Vascular, Inc.. Units affected: 1706 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1193-2023.