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U.S. Department of Health and Human Services

Class 2 Device Recall Protg GPS" Biliary Stent System

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  Class 2 Device Recall Protg GPS" Biliary Stent System see related information
Date Initiated by Firm April 22, 2008
Date Posted August 26, 2008
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-2169-2008
Recall Event ID 48614
510(K)Number K032580  
Product Classification Biliary catheter - Product Code FGE
Product Ev3 Protege GPS Biliary Stent Systems
6 mm, 60 mm, 120cm, .35, 6Fr, OTW
Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920
REF SERB65-06-60-120
Lot 2675311
Use before 2009-01-01
Sterile EO

Intended as a palliative treatment of malignant neoplasms in the biliary tree.
Code Information Lot 2675311
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		 A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
FDA Determined
Cause 2		 Employee error
Action The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
Quantity in Commerce 1
Distribution Nationwide Distribution --- state of LA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FGE and Original Applicant = EV3 INC
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