Device product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Z-2003-2026
Product summary
- Event
- Event 98637
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2003-2026
Official wording
Reason: catheter may experience resistance when being advanced over the guidewire
Code information: All Lot Numbers/UDI: 00884450816509
Distribution pattern: US Nationwide distribution in the state of CO.
Derived failure modes
-
Unknown
catheter may experience resistance when being advanced over the guidewire