Recalls / —

—#67901

Product

CORDIS "Fire Star" 3.00 x 20 Dilatation Catheter, Catalog # 80120300, Distributed by Cordis Corporation, Miami Lakes, FL 33014

FDA product code

LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device class

Class 2

Medical specialty

Cardiovascular

PMA numbers

P880003

Affected lot / code info

Lot #s: 13187449 13191017 13197627 13200868 13212426 13212427 13218323 13224191 13226740 13230694 13231290 13233901 13239280 13246361 13247919 13252930 13281217 13281229 13281239 13281288 13281300 13281345 13281429 13281441 13281458 13282485 13283825 13286193 13290338 13294211 13294557 13294558 13301371 13303085 13304561 13311788 13311789 13311798 13312722 13314188 13321832 and  13325101

Why it was recalled

Slow Deflation or No Deflation

Root cause (FDA determination)

Process control

Action the firm took

Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.

Recalling firm

Firm

Cordis Corporation

Address

14201 NW 60th Avenue, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern

Worldwide.

Timeline

Recall initiated

2008-01-14

Posted by FDA

2008-02-06

Terminated

2009-10-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #67901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.