FDA DeviceClass IINotable

FDA Recall: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669

Date: 2026-06-24
Brand: Merit Medical Systems, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to unsealed portions of pouches.

Hazard

Due to unsealed portions of pouches.

Remedy

5,004

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