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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 27, 2006
Date Posted April 05, 2006
Recall Status1 Terminated 3 on December 03, 2007
Recall Number Z-0708-06
Recall Event ID 34680
510(K)Number K041903  K944620  
Product Classification Colonoscope And Accessories, Flexible/Rigid - Product Code FDF
Product Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
Code Information Catalog Numbers:  EC-450HL5; EC-450LP5; EC-250HL5; EC-250LP5; EC-450HL5-UP; EC-450LP5-UP; EC-250HL5-UP; EC-250LP5-UP.  All lots
Recalling Firm/
Fujinon Inc
10 Highpoint Dr
Wayne NJ 07470-7431
For Additional Information Contact Charles J. Neff
Manufacturer Reason
for Recall
Colonoscope insertion tube is not bending properly and is stiff.
FDA Determined
Cause 2
Action Fujinon sent out a Technical Bulletin on 3/27/2006 that instructs the physician to do a bending test with the colonoscope. If the scope does not bend around an 8 inch bending diameter, the scope is not to be used.
Quantity in Commerce 2335 UNITS
Distribution Product is distributed nationwide to hospitals and physicians. It was shipped internationally to Canada. US Government accounts include VA medical centers in Spokane WA, St. Louis, MO and Camp Pendleton Naval Hospital in Camp Pendleton, CA.
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 = FDF and Original Applicant = FUJINON, INC.
510(K)s with Product Code = FDF and Original Applicant = MARKS & MURASE