FDA recall Z-1479-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-03-13

Report date

2018-05-02

Termination date

2021-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2018