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FDAJuly 21, 2021device

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

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

The hazard

There is a potential that a package sheath contains an incorrect dilator.

What to do

FDA enforcement status: Terminated

Brands named

merit medical systemsmeritmerit medical

UPCs

00884450015391

Recall history

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

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MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391 — Recall Details · AllClear