FDAJune 4, 2015device
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of d...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
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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