Z-0825-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- March 6, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Reason for Recall
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Distribution Pattern
US: WI, IL, NE, CA, OH, NY OUS: None
Code Information
Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.