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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-0730-2007
Recall Event ID 37628
510(K)Number K031186  
Product Classification Endoscopic Biliary Stent, - Product Code FGE
Product Flexxus™ Endoscopic Biliary Stent, 7.5 Fr
10 mm diameter x 60 mm length
Item Number: LXB10060
Code Information Lot Number: ANQJ0639
Recalling Firm/
Conmed Endoscopic Technologies, Inc.
129 Concord Rd Bldg 3
Billerica MA 01821-4600
For Additional Information Contact Beth Zis
Manufacturer Reason
for Recall
Blue safety clip incorrectly placed on the stent may prevent deployment
FDA Determined
Cause 2
Action ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
Quantity in Commerce 1 UNIT
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.