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FDAOctober 26, 2018device

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

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

The hazard

Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

What to do

FDA enforcement status: Terminated

Brands named

merit medical systemsmeritmerit medical

UPCs

00884450390580

Recall history

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

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