Date Initiated by Firm |
May 11, 2018 |
Create Date |
June 21, 2018 |
Recall Status1 |
Terminated 3 on May 05, 2020 |
Recall Number |
Z-2270-2018 |
Recall Event ID |
79998 |
510(K)Number |
K853585
|
Product Classification |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology - Product Code FET
|
Product |
Olympus JF-160F duodenoscopes (Model NumberJF-160F) |
Code Information |
All |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy PO Box 610 Center Valley PA 18034-0610
|
For Additional Information Contact |
Laura Storms 484-896-5000
|
Manufacturer Reason for Recall |
Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Firm is extending recall to the user level
Letters will be sent on May, 11, 2018 via overnight mail to customers
Follow-up phone calls to consignees to offer training on new reprocessing instructions
No action can be taken with hospitals that are no longer in business |
Quantity in Commerce |
68 |
Distribution |
Nationwide |
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 = FET and Original Applicant = OLYMPUS CORP.
|