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U.S. Department of Health and Human Services

Class 3 Device Recall Olympus Leak Test Kit Adapter

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  Class 3 Device Recall Olympus Leak Test Kit Adapter see related information
Date Initiated by Firm October 07, 2020
Create Date November 16, 2020
Recall Status1 Terminated 3 on July 14, 2021
Recall Number Z-0458-2021
Recall Event ID 86596
510(K)Number K181865  
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
Product Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning
Part number: 0600818OKN
Code Information Distributed from May 23, 2017 to June 30, 2020
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact SAME
440-392-7601
Manufacturer Reason
for Recall		 Potential for cleaning solution intrusion into endoscope
FDA Determined
Cause 2		 Device Design
Action Steris issued Urgent Medical Device Recall issued letter on 10/7/20 stating reason for recall, health risk and action to take: Please immediately inspect your facility for affected Leak Test Adapters that connect to Olympus endoscopes. The affected Leak Test Adapters have a white plastic valve connector. If you have this Leak Test Adapter, please disconnect from your Acu-sInQ Complete, destroy, and replace with the new Leak Test Adapter included with this Customer Notification Letter. 2. Please complete the Medical Device Recall Response Form included with this Customer Notification Letter. Your STERIS Sales Representative can assist you should you have any questions while completing the form, or when replacing the Leak Test Adapter. 3. Return the completed Medical Device Recall Response Form to STERIS via one of the following three methods: a. Visit https://www.steris.com/medical-device-recall-response-form and complete the form electronically; b. Scan and email the completed form to Regulatory_Compliance@STERIS.com; or c. Fax the completed form to (440) 392-8963. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Katilin Hawranko, Product Manager at (440) 392-7431, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.
Quantity in Commerce 293 units:248 units (USA); 45 units OUS
Distribution Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
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 = FEB and Original Applicant = STERIS Corporation
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