Angiodynamics, Inc. Recall 94035
Description: MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
Angiodynamics, Inc. Recall 94035 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1335-2024 |
| Event ID | 94035 |
| Event Description | MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA. |
| Quantity | 4366 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: 15051684022934 UPN: H965457501 Lot Number: 5784035 5784036 5784136 5787837 5788554 5788555 5789978 5790448 5790449 5791589 5791590 5791591 5797460 5797461 5798838 5799613 5799623 5800399 5804390 5806116 |
| Center Classification Date | 20240321 |
| Recall Initiation Date | 20240130 |
| Recalling Firm | Angiodynamics, Inc. |
| Initial Notification | Letter |
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