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FDASeptember 12, 2019device

Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.

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

The hazard

labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

What to do

FDA enforcement status: Terminated

Brands named

merit medical systemsmeritmerit medical

UPCs

00884450426357

Recall history

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

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