Recall Z-0286-2024— Cordis US Corp

Name: FDA recall Z-0286-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-26

Class I · Ongoing

Class I FDA medical device recall by Cordis US Corp, initiated 2023-09-26. It names one FDA 510(k) clearance: K970854. Product: Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter. Reason: Non-sterile product labeled as sterile was distributed..

Recalling firm: Cordis US Corp
Classification: Class I
Status: Ongoing
Initiated: 2023-09-26
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 CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Reason for recall

Non-sterile product labeled as sterile was distributed.

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