Z-2004-2026 Class II Ongoing
FDA device recall Z-2004-2026 was initiated by Merit Medical Systems, Inc. on April 2, 2026 and is designated Class II. Reason for recall: catheter may experience resistance when being advanced over the guidewire The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- April 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 Pattern
US Nationwide distribution in the state of CO.
Code Information
All Lot Numbers/UDI: 00884450024140