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U.S. Department of Health and Human Services

Class 2 Device Recall Complete SE Biliary Stent System, SC5120L (5 mm x 120 mm)

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 Class 2 Device Recall Complete SE Biliary Stent System, SC5120L (5 mm x 120 mm)see related information
Date Initiated by FirmJuly 17, 2009
Date PostedJanuary 19, 2010
Recall Status1 Terminated 3 on June 21, 2010
Recall NumberZ-0654-2010
Recall Event ID 53199
510(K)NumberK062264 
Product Classification Catheter, biliary, diagnostic - Product Code FGE
ProductComplete 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.
Code Information Lot Number: 0000983799, use by date 03/17/2011.
FEI Number 3001452571
Recalling Firm/
Manufacturer		 Medtronic CardioVascular
3576 Unocal Pl
Santa Rosa CA 95403
For Additional Information Contact
707-566-1548
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionMedtronic, 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 Commerce20 units
DistributionProduct was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = FGE
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