Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 0
FDA device recall Z-0655-2010 · posted 2010-01-19 · Terminated
Recall details
- Recalling firm
- Medtronic CardioVascular
- Reason for recall
- Mislabeling-- A lot of 5 mm x 12 mm stents were labeled as 6 mm x 80 mm stents and vice versa.
- Action taken
- Medtronic, Inc. issued an "Urgent - Voluntary Medical Device Recall" communication dated July 17, 2009 asking consignees to segregate labeled lot numbers until a representative from the firm arrived to retrieve the products. For further information, contact your local Medtronic representative or call Medtronic, Inc. at 1-707-525-0111.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 20 units
- Distribution
- Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
- Date initiated
- 2009-07-17
- Date posted
- 2010-01-19
- Date terminated
- 2010-06-21
- 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 |