| 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
|
|---|
