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.
FDA Recall Z-0654-2010 · Posted 2010-01-19
Recalling FirmMedtronic CardioVascular
Recall StatusTerminated
Product CodeFGE
Date Initiated2009-07-17
Date Terminated2010-06-21
Product Quantity20 units
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.