Recall Z-0003-2014— Cordis Corporation

Name: FDA recall Z-0003-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-12

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2013-08-12, terminated 2014-09-30. It names one FDA 510(k) clearance: K131225. Product: Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.. Reason: Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Terminated: 2014-09-30
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K131225 — ADROIT GUIDING CATHETERCordis Corp., A Johnson & Johnson Co.·cleared 2013-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

Reason for recall

Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.

Data sourced from openFDA. This site is unofficial and independent of the FDA.