FDA recall Z-2003-2026
Merit Medical Systems, Inc. · Class II · device
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Reason for recall
catheter may experience resistance when being advanced over the guidewire
Distribution
US Nationwide distribution in the state of CO.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-04-02
- Report date
- 2026-05-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- South Jordan, UT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2003-2026