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U.S. Department of Health and Human Services

Class 2 Device Recall Flexxus

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  Class 2 Device Recall Flexxus see related information
Date Initiated by Firm March 14, 2007
Date Posted April 11, 2007
Recall Status1 Terminated 3 on May 15, 2007
Recall Number Z-0729-2007
Recall Event ID 37628
510(K)Number K031186  
Product Classification Endoscopic Biliary Stent - Product Code FGE
Product Flexxus™ Endoscopic Biliary Stent, 7.5 Fr
10mm diameter x 40 mm length
Item Number: LXB10040
Code Information Lot Numbers: ANQJO636, ANQJO637
Recalling Firm/
Manufacturer		 Conmed Endoscopic Technologies, Inc.
129 Concord Rd Bldg 3
Billerica MA 01821-4600
For Additional Information Contact Beth Zis
978-964-4251
Manufacturer Reason
for Recall		 Blue safety clip incorrectly placed on the stent may prevent deployment
FDA Determined
Cause 2		 Other
Action ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
Quantity in Commerce 11 UNITS
Distribution Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.
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 = C.R. BARD, INC.
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