Z-0654-2010
Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, use...
Medtronic, Inc. / initiated 2009-07-17 / Terminated / root cause: labeling and UDI
Medtronic CardioVascular began a recall of 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... on . The reason FDA records is "Mislabeling-- A lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0654-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- 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.
- Product code
- FGE Stents, Drains And Dilators For The Biliary Ducts
- Reason for recall
- Mislabeling-- A lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa.
- Root cause tag
- labeling and UDI
- FDA 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 in commerce
- 20 units
- Distribution
- Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
- Product codes and lots
- Lot Number: 0000983799, use by date 03/17/2011.
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