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Terminated

Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040

FDA Recall Z-0729-2007 · Posted 2007-04-11

Recalling FirmConmed Endoscopic Technologies, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2007-03-14
Date Terminated2007-05-15
Product Quantity11 UNITS

Reason for Recall

Blue safety clip incorrectly placed on the stent may prevent deployment

Firm Action

ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.

Root Cause

Other

Distribution Pattern

Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031186LUMINEXX ENDOSCOPIC BILIARY STENTC.R. Bard, Inc. · 2003-05-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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