FDAFebruary 16, 2017device
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaini...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.
What to do
FDA enforcement status: Terminated
Brands named
merit medical systemsmeritmerit medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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