FDA Device recall Z-1195-2023
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 by Unetixs Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1195-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-10 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Unetixs Vascular |
| Distribution | US |
Product
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
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.
Identifiers
| code_info | All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1195-2023%22
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