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Recall Observatory FDA recall evidence

Device product

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

Z-1195-2023

February 10, 2023

Class II

Product summary

Firm
Unetixs Vascular, Inc.
Event
Event 91564
Status
Ongoing
Classification
Class II
Quantity
2000 units
Official record key
device-enforcement:Z-1195-2023

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

    reason.no_named_rule · v1.0.0

    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.