Z-0379-2022 Class II Ongoing
FDA device recall Z-0379-2022 was initiated by Olympus Corporation of the Americas on November 2, 2021 and is designated Class II. Reason for recall: 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 infe… The recall status is ongoing. Affected quantity: 14,447 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 2, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,447 units
Product Description
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
All serial numbers. UDI: 04953170339967