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Class 2 Device Recall Complete SE Biliary Stent System, SC680L (6 mm x 120 mm) |
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Date Initiated by Firm |
July 17, 2009 |
Date Posted |
January 19, 2010 |
Recall Status1 |
Terminated 3 on June 21, 2010 |
Recall Number |
Z-0655-2010 |
Recall Event ID |
53199 |
510(K)Number |
K062264
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Product Classification |
Catheter, biliary, diagnostic - Product Code FGE
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Product |
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. |
Code Information |
Lot Number: 0000983806, use by date 03/17/2011. |
Recalling Firm/ Manufacturer |
Medtronic CardioVascular 3576 Unocal Pl Santa Rosa CA 95403
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For Additional Information Contact |
707-566-1548
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FGE and Original Applicant = MEDTRONIC VASCULAR
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