Device product
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Z-1196-2023
Product summary
- Event
- Event 91564
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 984 units
- Official record key
device-enforcement:Z-1196-2023
Official wording
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.
Code information: All Serial Numbers
Distribution pattern: Worldwide distribution - US Nationwide and Global distribution.
Derived failure modes
-
Unknown
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.