FDA Medical Device Recalls (openFDA)
Unetixs Vascular, Inc.: MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
- Recall number
- Z-1196-2023
- Recalling firm
- Unetixs Vascular, Inc.
- Product
- MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
- Status
- Open, Classified
- Initiated
- 2023-02-10
- Posted
- 2023-03-01
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Use error
- Action
- Urgent Medical Device Notification letters were sent to customers beginning 2/10/23. In order to physically prevent device misconnections from occurring, standardized connector designs for specific medical applications have been developed in accordance with ISO-80369-5. Unetixs Vascular has adopted this standard and ceased shipment of devices, hoses and blood pressure accessories equipped with luer fittings. All new devices will ship with bayonet connectors. These new connectors are designed to help reduce the risk for medical device misconnection. Action Items: 1. Immediately order one Bayonet Conversion Kit (BCK) per device via our website, www.unetixs.com/shop, to replace every air tubing connector on the device. 2. Complete the enclosed recall return response form. There is no need to return any product/accessories to Unetixs Vascular. Thank you for your attention to this matter. Unetixs Vascular is committed to providing high-quality products and partnering with you to ensure the safety of each patient. Please address any questions you may have with your local Sales Representative or our customer service department at 800-486-3849. If you are no longer in possession of this device, please ensure this notification gets to the current user. Please visit the following link for additional Examples of Medical Device Misconnections: https://www.fda.gov/medical-devices/medical-device-connectors/examples-medical-device-misconnections
- Quantity
- 984 units
- Distribution
- Worldwide distribution - US Nationwide and Global distribution.
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K904392"]
- PMA numbers
- not on file
- Product code
- JAF
- Firm FEI
- 1222117
- Firm city
- Warwick
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28