FDA Enforcement
Class II
Ongoing
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Recall: Z-0379-2022
·
Reported December 22, 2021
Enforcement
- Recall Number
- Z-0379-2022
- Event ID
- 88981
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 22, 2021
- Initiation Date
- November 2, 2021
- Classification Date
- December 10, 2021
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Reason
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
Code Info
All serial numbers. UDI: 04953170339967
Distribution
US Nationwide distribution.
Quantity
14,447 units