FDAFDA · Food and drugs·Recall number Z-1261-2022
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Published June 22, 2022 · Recall initiated: April 27, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to incorrect size and configuration labeling of the detachable coil system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro Therapeutics, Inc.
- Distributor
- International distribution in the countries of China and Republic of Korea.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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