Recall Z-0324-2018— Cordis Corporation

Name: FDA recall Z-0324-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-15

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2017-11-15, terminated 2019-11-04. It names one FDA 510(k) clearance: K121125. Product: Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.. Reason: Potential for cracked luer hubs.

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-11-15
Terminated: 2019-11-04
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121125 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc.·cleared 2012-07-06

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 S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.

Reason for recall

Potential for cracked luer hubs

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