medical Class II Updated 2025-04-02

Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F1

Recalled Product

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D


Hazard / Issue

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

Issued by

FDA

Distribution: International distribution to the country of Japan.
Lot/Code Info: UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
View official government recall

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