Unetixs Vascular, Inc. MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Brand
Unetixs Vascular, Inc.
Lot Codes / Batch Numbers
All Serial Numbers
Products Sold
All Serial Numbers
Unetixs Vascular, Inc. is recalling MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01 due to 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 emb. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026