Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nic
FDA device recall Z-0642-2009 · posted 2009-03-18 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiovascular
- Reason for recall
- Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.
- Action taken
- Medtronic sent a notification entitled "URGENT - VOLUNTARY MEDICAL DEVICE RECALL" to consignees on 11/21/2008. All products are to be returned to the firm's distribution center. For further information, please contact Medtronic Cardiovascular by telephone at 707-566-0111.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 23 units
- Distribution
- Nationally in the states of NY, TX, CA, IA, AZ, PA, IN, and KS.
- Date initiated
- 2008-11-24
- Date posted
- 2009-03-18
- Date terminated
- 2009-03-27
- Location
- Santa Rosa, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM (K062264) | Medtronic Vascular | 2007-11-08 |