Z-1261-2022 Class II Ongoing
FDA device recall Z-1261-2022 was initiated by Micro Therapeutics, Inc. on Apr 27, 2022 and is designated Class II. Reason for recall: Due to incorrect size and configuration labeling of the detachable coil system. The recall status is ongoing. Affected quantity: 96 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 22, 2022
- Initiation Date
- Apr 27, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 systems
Product Description
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Reason for Recall
Due to incorrect size and configuration labeling of the detachable coil system.
Distribution Pattern
International distribution in the countries of China and Republic of Korea.
Code Information
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