MultiLab Series II REVO non-invasive vascular recall
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Why was MultiLab Series II REVO 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 REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
- Recalling firm
- Unetixs Vascular, Inc.
- Quantity
- 984 units
- Distribution
- Worldwide distribution - US Nationwide and Global distribution.
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)