Date Initiated by Firm |
December 23, 2015 |
Create Date |
May 31, 2016 |
Recall Status1 |
Terminated 3 on January 18, 2018 |
Recall Number |
Z-1861-2016 |
Recall Event ID |
73469 |
510(K)Number |
K944759
|
Product Classification |
duodenoscope and accessories, flexible/rigid - Product Code FDT
|
Product |
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
|
Code Information |
All distribution dates :3/2003-4/2016 |
Recalling Firm/ Manufacturer |
Fujifilm Medical Systems U.S.A., Inc. 10 Highpoint Dr Wayne NJ 07470-7431
|
For Additional Information Contact |
Mrs. Faye Dunn 973-709-2202
|
Manufacturer Reason for Recall |
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
|
FDA Determined Cause 2 |
Other |
Action |
Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015. |
Quantity in Commerce |
98 units |
Distribution |
Nationwide Distribution. |
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 = FDT and Original Applicant = FUJINON, INC.
|