Recall Z-0720-2023— Cordis US Corp

Name: FDA recall Z-0720-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-07

Class II · Ongoing

Class II FDA medical device recall by Cordis US Corp, initiated 2022-11-07. It names one FDA 510(k) clearance: K970854. Product: Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.. Reason: There is a potential for separation at the male connector..

Recalling firm: Cordis US Corp
Classification: Class II
Status: Ongoing
Initiated: 2022-11-07
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K970854 — 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERCordis Corp.·cleared 1997-09-30

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 Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

Reason for recall

There is a potential for separation at the male connector.

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