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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1261-2022
Event ID90178
Event DescriptionAXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Product TypeDevices
DistributionInternational distribution in the countries of China and Republic of Korea.
Quantity96 systems
Recall ReasonDue to incorrect size and configuration labeling of the detachable coil system.
Device Classification20220622
Device Code InfoProduct 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 Date20220613
Recall Initiation Date20220427
Recalling FirmMicro Therapeutics, Inc.
Initial Notification Letter
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