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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-0812-2008
Recall Event ID 46378
PMA Number P880003 
Product Classification Dilatation Catheter - Product Code LOX
Product CORDIS "Fire Star" 2.50 x 20 Dilatation Catheter, Catalog # 80120250, Distributed by Cordis Corporation, Miami Lakes, FL 33014
Code Information Lot #s: 13187448 13191357 13197625 13197626 13203922 13203923 13212424 13212425 13224187 13224189 13225882 13231288 13232326 13233516 13236343 13237912 13242129 13246360 13247918 13252929 13253835 13270369 13279283 13280403 13281233 13281287 13281301 13281328 13281330 13281333 13281392 13281399 13281427 13282483 13283210 13285523 13288830 13290337 13292699 13294554 13297302 13302302 13306834 13311785 13313289 13314187 13315462 13316298 13317745 13321822 13325807 13325808 
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 52 Ea
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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