FDAHealthApril 2, 2026

Merit Medical Systems, Inc. — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

⚠️ catheter may experience resistance when being advanced over the guidewire

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 2, 2026

US Nationwide distribution in the state of CO.

What's affected?

Product: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Brand: Merit Medical Systems, Inc.
Lot code: /UDI:

Additional details

All Lot Numbers/UDI: 00884450816509

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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