Angiodynamics, Inc. Recall 94035
Description: MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
Angiodynamics, Inc. Recall 94035 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1346-2024 |
| Event ID | 94035 |
| Event Description | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA. |
| Quantity | 65 units |
| Recall Reason | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case |
| Device Classification | 20240327 |
| Device Code Info | UDI: 15051684023184 UPN: H965457751 Lot Number: 5790680 5798831 5806100 |
| Center Classification Date | 20240321 |
| Recall Initiation Date | 20240130 |
| Recalling Firm | Angiodynamics, Inc. |
| Initial Notification | Letter |
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