FDA Enforcement
Class II
Ongoing
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Recall: Z-2004-2026
·
Reported May 6, 2026
Enforcement
- Recall Number
- Z-2004-2026
- Event ID
- 98637
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Merit Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 6, 2026
- Initiation Date
- April 2, 2026
- Classification Date
- April 29, 2026
- Address
- 1600 W Merit Pkwy, South Jordan, UT, 84095-2416, United States
Description
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Reason
catheter may experience resistance when being advanced over the guidewire
Code Info
All Lot Numbers/UDI: 00884450024140
Distribution
US Nationwide distribution in the state of CO.