Axium Detachable Coil System recall: Labeling Error
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Why was Axium Detachable Coil System recalled?
Due to incorrect size and configuration labeling of the detachable coil system.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
- Recalling firm
- Micro Therapeutics, Inc.
- Quantity
- 96 systems
- Distribution
- International distribution in the countries of China and Republic of Korea.
- Recall date
- June 22, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)