FDAFDA · Food and drugs·Recall number Z-2004-2026
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Published May 6, 2026 · Recall initiated: April 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
catheter may experience resistance when being advanced over the guidewire
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- US Nationwide distribution in the state of CO.
- Lot
- All Lot Numbers/UDI: 00884450024140
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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