Z-2270-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2018
- Initiation Date
- May 11, 2018
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68
Product Description
Olympus JF-160F duodenoscopes (Model NumberJF-160F)
Reason for Recall
Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
Distribution Pattern
Nationwide
Code Information
All