Merit Medical Systems, Inc. Recall 94304
Description: Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems, Inc. Recall 94304 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1874-2024 |
| Event ID | 94304 |
| Event Description | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada. |
| Quantity | 18 units |
| Recall Reason | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. |
| Device Classification | 20240529 |
| Device Code Info | Lot # H2800643/ UDI: 00884450770757 |
| Center Classification Date | 20240520 |
| Recall Initiation Date | 20240314 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
| Similar To |