Angiodynamics, Inc. Recall 94349
Description: DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
Angiodynamics, Inc. Recall 94349 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1762-2024 |
Event ID | 94349 |
Event Description | DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035 |
Product Type | Devices |
Distribution | VA |
Quantity | 35 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: 25051684014752 Lot Numbers: 5805839 |
Center Classification Date | 20240503 |
Recall Initiation Date | 20240318 |
Recalling Firm | Angiodynamics, Inc. |
Initial Notification | Letter |
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