Warwick, RI, United States
Unetixs Vascular, Inc. recalls
1 recall recorded since 2018, most recently on 10 February 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 February 2023
- 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.
- Distribution
- Worldwide distribution - US Nationwide and Global distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1195-2023, Z-1193-2023, Z-1196-2023, Z-1194-2023
- MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
- MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
- MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
- MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.