Z-1479-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- March 13, 2018
- Termination Date
- May 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 855 units
Product Description
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Reason for Recall
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.
Distribution Pattern
US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Code Information
UDI 20643169689309, Lot Number 60074805