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Recall Observatory FDA recall evidence

Device product

Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.

Z-1479-2018

March 13, 2018

Class II

Product summary

Firm
Medtronic Vascular
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

    reason.no_named_rule · v1.0.0

    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.