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U.S. Department of Health and Human Services

Class 1 Device Recall Fire Star

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  Class 1 Device Recall Fire Star see related information
Date Initiated by Firm January 14, 2008
Date Posted February 06, 2008
Recall Status1 Terminated 3 on October 20, 2009
Recall Number Z-0789-2008
Recall Event ID 46378
PMA Number P880003 
Product Classification Dilatation Catheter - Product Code LOX
Product CORDIS "Fire Star" 2.00 x 10, Dual Marker Band, Dilatation Catheter, Catalog # 8011020D, Distributed by Cordis Corporation, Miami Lakes, FL 33014
Code Information Lot #s: 13188605 13192861 13195491 13205387 13212421 13214548 13222778 13224932 13227002 13230714 13232858 13237698 13237904 13245573 13258620 13260780 13267186 13281342 13281424 13282061 13290334 13291893 13293578 13293670 13295101 13304555 13305488 13309108 13313284 13319350 and 13321696 
Recalling Firm/
Cordis Corporation
14201 NW 60th Avenue
Miami Lakes FL 33014-2802
For Additional Information Contact
Manufacturer Reason
for Recall
Slow Deflation or No Deflation
FDA Determined
Cause 2
Process control
Action 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.
Quantity in Commerce 133,300 units total for recalls Z-0747-0824-2008
Distribution Worldwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LOX and Original Applicant = CORDIS CORP.