Recall Z-0655-2010 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Medtronic CardioVascular
Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliation of malignant neoplasms in the biliary tree.
| Date | Jan 19, 2010 (initiated Jul 17, 2009) |
| Status | Terminated |
| Reason | Mislabeling-- A lot of 5 mm x 12 mm stents were labeled as 6 mm x 80 mm stents and vice versa. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 20 units |
| Distribution | Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062264 | COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM Medtronic Vascular, Nov 8, 2007 |