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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 Flexxussee related information
Date Initiated by FirmMarch 14, 2007
Date PostedApril 11, 2007
Recall Status1 Terminated 3 on May 15, 2007
Recall NumberZ-0730-2007
Recall Event ID 37628
510(K)NumberK031186 
Product Classification Endoscopic Biliary Stent, - Product Code FGE
ProductFlexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number: LXB10060
Code Information Lot Number: ANQJ0639
Recalling Firm/
Manufacturer
Conmed Endoscopic Technologies, Inc.
129 Concord Rd Bldg 3
Billerica MA 01821-4600
For Additional Information ContactBeth Zis
978-964-4251
Manufacturer Reason
for Recall
Blue safety clip incorrectly placed on the stent may prevent deployment
FDA Determined
Cause 2
Other
ActionConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
Quantity in Commerce1 UNIT
DistributionWorldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.
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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