[Recalled] MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 — The current luer fittings and adaptors allow for the possibility of the air lin… | FDA 2023-02-10
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 |
|---|---|
| Brand / manufacturer | Unetixs Vascular, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1195-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 February 2023 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Unetixs Vascular, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.