Recall Z-1194-2023 ยท JAF Monitor, Ultrasonic, Nonfetal
Unetixs Vascular, Inc.
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
| Date | Mar 1, 2023 (initiated Feb 10, 2023) |
| Status | Open, Classified |
| 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 Bayo |
| Quantity | 2310 units |
| Distribution | Worldwide distribution - US Nationwide and Global distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904392 | MULTILAB 2000 Unetixs, Inc., Apr 29, 1991 |