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/ Manufacturer |
Fujinon Inc 10 Highpoint Dr Wayne NJ 07470-7431
|
For Additional Information Contact |
Charles J. Neff 973-686-2447
|
Manufacturer Reason for Recall |
Colonoscope insertion tube is not bending properly and is stiff.
|
FDA Determined Cause 2 |
Other |
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
|