MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
- Company
- Unetixs Vascular, Inc.
- Recall Initiated
- February 10, 2023
- Posted
- March 1, 2023
- Recall Number
- Z-1193-2023
- Quantity
- 1706 units
- Firm Location
- Warwick, RI
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.
Distribution
Worldwide distribution - US Nationwide and Global distribution.
Lot / Code Info
All Serial Numbers
Root Cause
Use error
Action Taken
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