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

Recall date

March 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1479-2018

FDA classification

Class II

Brand / firm

Medtronic Vascular

Sold / distributed

US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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