FDA recall Z-0458-2021

Product

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

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

Key facts

Status

Terminated

Initiation date

2020-10-07

Report date

2020-11-25

Termination date

2021-07-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2021