FDA DevicesClass II
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Published: May 6, 2026Recall ID: Z-2003-2026Category: devicesCountry: US
Reason for Recall / Hazard
catheter may experience resistance when being advanced over the guidewire
Product Description & Identification
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Affected Products
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Additional Source Details
| Field | Value |
|---|---|
| City | South Jordan |
| State | UT |
| Event id | 98637 |
| Address 1 | 1600 W Merit Pkwy |
| Code info | All Lot Numbers/UDI: 00884450816509 |
| Postal code | 84095-2416 |
| Report date | 20260506 |
| Product type | Devices |
| Reason for recall | catheter may experience resistance when being advanced over the guidewire |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | Letter |
| Center classification date | 20260429 |
Overview
- Recalling FirmMerit Medical Systems, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of CO.