Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, 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.
Recall
- Recall Number
- Z-0654-2010
- Event Number
- 53199
- Firm
- Medtronic CardioVascular
- FEI Number
- 3001452571
- Product Code
- FGE
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- July 17, 2009
- Posted
- January 19, 2010
- Terminated
- June 21, 2010
- Address
- 3576 Unocal Pl, Santa Rosa, CA, 95403
Description
Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, 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.
Mislabeling-- A lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa.
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.
Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
20 units