FDA-Device2018-05-02Class II
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Medtronic Vascular
Hazard
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.
Sold states
US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Affected count
855 units
Manufactured in
35-37A Cherry Hill Drive, N/A, Danvers, MA, United States
Products
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2018Don't want to check this manually?
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