—#67896

Product

CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D, 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: 13187447 13191356 13197623 13197624 13200866 13200867 13206136 13206138 13212422 13212423 13218318 13223383 13225879 13225880 13225881 13227558 13233514 13236342 13237910 13244058 13244489 13246359 13246860 13247917 13251136 13252924 13254620 13281299 13281397 13281453 13282066 13282067 13284574 13288058 13289756 13296516 13296517 13318532 13321817 and 13325804

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 #67896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.