Z-1196-2023Class II

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

Name: Z-1196-2023 MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Creator: Unetixs Vascular, Inc.
Published: 2023-02-10
License: https://open.fda.gov/license/

Unetixs Vascular, Inc. / initiated 2023-02-10 / Open, Classified

FDA source

Unetixs Vascular, Inc. began a recall of MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01 on 2023-02-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1196-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-10
Posted: 2023-03-01
Recalling firm: Unetixs Vascular, Inc.
Product: MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Product code: JAF Monitor, Ultrasonic, Nonfetal
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.
FDA 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 in commerce: 984 units
Distribution: Worldwide distribution - US Nationwide and Global distribution.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1196-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1193-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01
Z-1194-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01
Z-1195-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01
Z-1196-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01

Product code JAF

K904392Class IIMultilab 2000Unetixs, Inc. / cleared 1991-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)