FDAFDA · Food and drugs·Recall number Z-1047-2022
BF-3C160: EVIS EXERA Bronchovideoscope
Published May 18, 2022 · Recall initiated: March 8, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution.
- Lot
- All serial numbers. UDI: 04953170340031
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.