Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolizati
FDA device recall Z-0841-2012 · posted 2012-01-24 · Terminated
Recall details
- Recalling firm
- Micro Therapeutics Inc, dba ev3 Neurovascular
- Reason for recall
- ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.
- Action taken
- ev3 Neurovascular sent a "NOTIFICATION OF RECALL" letter dated November 6, 2008 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop use and segregate the affected product from inventory. A reply form was attached to the letter for customers to complete and fax to Customer Service at (763)398-7001. Customer Service will issue an RGA number for the return of the affected product. Contact the Quality Systems Manager at (949) 680-1305 for questions regarding this notice.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HCG
- Quantity affected
- 16
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, CT, NE, NV, and WI. and the countries of Argentina, Brazil, Colombia, and Egypt.
- Date initiated
- 2008-11-12
- Date posted
- 2012-01-24
- Date terminated
- 2012-01-26
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FX DETACHABLE COIL SYSTEM (K060747) | Micro Therapeutics, Inc. | 2007-04-24 |