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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 Starsee related information
Date Initiated by FirmJanuary 14, 2008
Date PostedFebruary 06, 2008
Recall Status1 Terminated 3 on October 20, 2009
Recall NumberZ-0800-2008
Recall Event ID 46378
PMA NumberP880003 
Product Classification Dilatation Catheter - Product Code LOX
ProductCORDIS "Fire Star" 2.00 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011520S, Distributed by Cordis Corporation, Miami Lakes, FL 33014
Code Information Lot #s: 13222781 13224941 13232861 13248678 13258624 13262747 13265034 13281409 13293676 13296514 13320188 and 13329054 
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
ActionCordis 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 Commerce133,300 units total for recalls Z-0747-0824-2008
DistributionWorldwide.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LOX
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