Recall Z-0250-2020— Cordis Corporation

Name: FDA recall Z-0250-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-04

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2019-10-04, terminated 2020-12-14. It names one FDA 510(k) clearance: K991811. Product: Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.. Reason: Product was manufactured utilizing an expired inner body..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-10-04
Terminated: 2020-12-14
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K991811 — CORDIS MAXI DS PTA BALLOON CATHETERCordis Corp.·cleared 1999-06-15

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 MAXI LD PTA Dilatation Catheter, for cardiovascular use.

Reason for recall

Product was manufactured utilizing an expired inner body.

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