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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-0799-2008
Recall Event ID 46378
PMA Number P880003 
Product Classification Dilatation Catheter - Product Code LOX
Product CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, Distributed by Cordis Corporation, Miami Lakes, FL 33014
Code Information Lot #s: 13187444 13191354 13191804 13191806 13197619 13199595 13211692 13214551 13218320 13221410 13221411 13224181 13224183 13227940 13229366 13230718 13237908 13242132 13244057 13246357 13247914 13251133 13255710 13262746 13268852 13281396 13281411 13282063 13283824 13283830 13283831 13284569 13285521 13288833 13289751 13291895 13295105 13297306 13301370 13304557 13309111 13313286 13316796 13321809 and 13323516 
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Avenue
Miami Lakes FL 33014-2802
For Additional Information Contact
786-313-2000
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.
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