FDA recall Z-1048-2022

Olympus Corporation of the Americas · Class II · device

Product

BF-MP160F: EVIS EXERA Bronchofibervideoscope

Reason for recall

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2022-03-08
Report date: 2022-05-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2022