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Medtronic Vascular recalls Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Recalled May 2, 2018 · FDA recall Z-1479-2018 · 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. · FDA Class II
Units
855 units
Sold at
US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Description
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.
Product
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Manufacturer(s)
Medtronic Vascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →