Angiodynamics, Inc. Recall 94349
Description: DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
Angiodynamics, Inc. Recall 94349 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1770-2024 |
| Event ID | 94349 |
| Event Description | DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055 |
| Product Type | Devices |
| Distribution | VA |
| Quantity | 260 units |
| Recall Reason | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| Device Classification | 20240515 |
| Device Code Info | UDI-DI: 25051684011850 Lot Numbers: 5809646 |
| Center Classification Date | 20240503 |
| Recall Initiation Date | 20240318 |
| Recalling Firm | Angiodynamics, Inc. |
| Initial Notification | Letter |
| Similar To |