Z-0458-2021 Class III Terminated
FDA device recall Z-0458-2021 was initiated by Steris Corporation on October 7, 2020 and is designated Class III. Reason for recall: Potential for cleaning solution intrusion into endoscope The recall status is terminated (terminated July 14, 2021). Affected quantity: 293 units:248 units (USA); 45 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- October 7, 2020
- Termination Date
- July 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 293 units:248 units (USA); 45 units OUS
Product Description
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Reason for Recall
Potential for cleaning solution intrusion into endoscope
Distribution Pattern
Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
Code Information
Distributed from May 23, 2017 to June 30, 2020