medical Class II Updated 2022-06-22

Micro Therapeutics, Inc. recalls AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Det

Recalled Product

AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;


Hazard / Issue

Due to incorrect size and configuration labeling of the detachable coil system.

Issued by

FDA

Distribution: International distribution in the countries of China and Republic of Korea.
Lot/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
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