Z-1048-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- March 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 292 units
Product Description
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 Pattern
US Nationwide distribution.
Code Information
All serial numbers. UDI: 04953170289064