Micro Therapeutics, Inc. Recall 90178
Description: AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Micro Therapeutics, Inc. Recall 90178 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1261-2022 |
| Event ID | 90178 |
| Event Description | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D; |
| Product Type | Devices |
| Distribution | International distribution in the countries of China and Republic of Korea. |
| Quantity | 96 systems |
| Recall Reason | Due to incorrect size and configuration labeling of the detachable coil system. |
| Device Classification | 20220622 |
| Device Code Info | Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079 Product Number: QC-10-30-3D UDI-DI (GTIN) Code: 00847536030138 Lot Number: B240084 |
| Center Classification Date | 20220613 |
| Recall Initiation Date | 20220427 |
| Recalling Firm | Micro Therapeutics, Inc. |
| Initial Notification | Letter |
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