Angiodynamics, Inc. Recall 94903
Description: SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Angiodynamics, Inc. Recall 94903 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2453-2024 |
| Event ID | 94903 |
| Event Description | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 519 boxes |
| Recall Reason | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) |
| Device Classification | 20240807 |
| Device Code Info | UPN: H787107327025 UDI-DI: 25051684009789 (Box) 15051684009782 (Pouch) Lot Number: A0424035 |
| Center Classification Date | 20240731 |
| Recall Initiation Date | 20240618 |
| Recalling Firm | Angiodynamics, Inc. |
| Initial Notification | Letter |
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