Date Initiated by Firm | January 14, 2008 |
Date Posted | February 06, 2008 |
Recall Status1 |
Terminated 3 on October 20, 2009 |
Recall Number | Z-0786-2008 |
Recall Event ID |
46378 |
PMA Number | P880003 |
Product Classification |
Dilatation Catheter - Product Code LOX
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Product | CORDIS "Dura Star" 4.00 x 30 Dilatation Catheter, Catalog # 70130400, Distributed by Cordis Corporation, Miami Lakes, FL 33014 |
Code Information |
Lot #s: 13208760 13273941 and 13287296 |
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 |
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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.
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PMA Database | PMAs with Product Code = LOX
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