—#184131

Product

Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

FDA product code: FEB — Accessories, Cleaning, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K181865
Affected lot / code info: Distributed from May 23, 2017 to June 30, 2020

Why it was recalled

Potential for cleaning solution intrusion into endoscope

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates

Timeline

Recall initiated: 2020-10-07
Terminated: 2021-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.