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.
This recall has been terminated (originally issued January 19, 2010).
- Company
- Medtronic Cardiovascular
- Recall Initiated
- July 17, 2009
- Posted
- January 19, 2010
- Terminated
- June 21, 2010
- Recall Number
- Z-0655-2010
- Quantity
- 20 units
- Firm Location
- Santa Rosa, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
Lot / Code Info
Lot Number: 0000983806, use by date 03/17/2011.
Root Cause
Labeling mix-ups
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.
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