Recall Z-0458-2021 ยท FEB Accessories, Cleaning, For Endoscope
Steris Corporation
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
| Date | Oct 7, 2020 |
| Status | Terminated |
| Reason | Potential for cleaning solution intrusion into endoscope |
| Root cause | 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. Yo |
| Quantity | 293 units:248 units (USA); 45 units OUS |
| Distribution | Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System STERIS Corporation, Dec 14, 2018 |