Recall Z-0458-2021

Reason for recall

Potential for cleaning solution intrusion into endoscope

FDA-determined cause: Device Design

Action taken

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.