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U.S. Department of Health and Human Services

Class 2 Device Recall MultiLab Series II

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  Class 2 Device Recall MultiLab Series II see related information
Date Initiated by Firm February 10, 2023
Date Posted March 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1194-2023
Recall Event ID 91564
510(K)Number K904392  
Product Classification Monitor, ultrasonic, nonfetal - Product Code JAF
Product MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Unetixs Vascular, Inc.
333 Strawberry Field Rd Ste 11
Warwick RI 02886-2459
For Additional Information Contact Mr. John Haefele
401-583-0089
Manufacturer 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 Determined
Cause 2		 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 2310 units
Distribution Worldwide distribution - US Nationwide and Global distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAF and Original Applicant = UNETIXS, INC.
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