MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Reported: March 8, 2023 Initiated: February 10, 2023 #Z-1195-2023
Product Description
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
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.
Details
- Recalling Firm
- Unetixs Vascular, Inc.
- Units Affected
- 2000 units
- Distribution
- Worldwide distribution - US Nationwide and Global distribution.
- Location
- Warwick, RI
Frequently Asked Questions
What product was recalled? ▼
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01. Recalled by Unetixs Vascular, Inc.. Units affected: 2000 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1195-2023.
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