Device product
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Z-1479-2018
Product summary
- Event
- Event 79591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 855 units
- Official record key
device-enforcement:Z-1479-2018
Official wording
Reason: The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
Code information: UDI 20643169689309, Lot Number 60074805
Distribution pattern: US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Derived failure modes
-
Unknown
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.