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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-0802-2008
Recall Event ID 46378
PMA Number P880003 
Product Classification Dilatation Catheter - Product Code LOX
Product CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, Distributed by Cordis Corporation, Miami Lakes, FL 33014
Code Information Lot #s: 13187445 13191016 13191800 13197620 13197621 13200143 13200144 13200145 13218321 13221412 13221413 13222784 13224943 13224944 13230719 13235886 13237909 13246358 13247915 13252066 13253834 13265037 13268858 13279599 13281193 13281201 13281202 13281224 13281267 13281302 13281318 13281390 13281431 13281450 13282064 13283832 13284570 13285522 13288834 13289754 13292702 13293582 13293583 13295106 13298196 13304558 13306300 13307100 13310118 13310119 13313287 13313288 13318531 13320190 13321811 and 13324440 
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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