Unetixs Vascular, Inc. Recall 91564
Description: MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Unetixs Vascular, Inc. Recall 91564 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1195-2023 |
| Event ID | 91564 |
| Event Description | MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and Global distribution. |
| Quantity | 2000 units |
| Recall 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. |
| Device Classification | 20230308 |
| Device Code Info | All Serial Numbers |
| Center Classification Date | 20230301 |
| Recall Initiation Date | 20230210 |
| Recalling Firm | Unetixs Vascular, Inc. |
| Initial Notification | Letter |
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