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FDAFebruary 10, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

unetixs vascularunetixs

UPCs

11986000001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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