Z-1196-2023 Class II Ongoing
FDA device recall Z-1196-2023 was initiated by Unetixs Vascular, Inc. on February 10, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 984 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- February 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 984 units
Product Description
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Reason for Recall
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 Pattern
Worldwide distribution - US Nationwide and Global distribution.
Code Information
All Serial Numbers