FDAClass IIMarch 8, 2023

MultiLab Series II LHS TI & ERGO non-invasive vascular recall

MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

Why was MultiLab Series II LHS TI & ERGO non-invasive vascular 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Serial Numbers

Product
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
Recalling firm
Unetixs Vascular, Inc.
Quantity
2310 units
Distribution
Worldwide distribution - US Nationwide and Global distribution.
Recall date
March 8, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls