Access Vascular, Inc Recall 91529
Description: HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Access Vascular, Inc Recall 91529 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1155-2023 |
| Event ID | 91529 |
| Event Description | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, TX, WA. |
| Quantity | 155 units |
| Recall Reason | Product Mislabeled on the outer bag and inner kit Tyvek header bag |
| Device Classification | 20230301 |
| Device Code Info | UDI: (01)00850030354020 Lot Number: 11434018 |
| Center Classification Date | 20230222 |
| Recall Initiation Date | 20221222 |
| Recalling Firm | Access Vascular, Inc |
| Initial Notification | Letter |
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