FDA-Device2020-11-25Class III
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Steris Corporation
Hazard
Potential for cleaning solution intrusion into endoscope
Sold states
Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
Affected count
293 units:248 units (USA); 45 units OUS
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2021Don't want to check this manually?
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