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U.S. Department of Health and Human Services

Class 2 Device Recall LuMend OUTBACK LTD

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  Class 2 Device Recall LuMend OUTBACK LTD see related information
Date Initiated by Firm August 20, 2008
Date Posted October 31, 2008
Recall Status1 Terminated 3 on December 01, 2008
Recall Number Z-0279-2009
Recall Event ID 49392
510(K)Number K001577  K014117  K043534  K040771  K032298  
Product Classification Vascular Catheter - Product Code MCW
Product Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The cannula is a nitinol needle that is used to re-enter the true lumen of the vessel.
Code Information All lots
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Avenue
Miami Lakes FL 33014
For Additional Information Contact Hal Baden
786-313-2000
Manufacturer Reason
for Recall		 The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula.
FDA Determined
Cause 2		 Other
Action U.S. Customers - A Notification of Recall Letter with an Acknowledgement Form was sent overnight to 5 individuals in each account on 08/18/2008. For non-U.S. customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries (08/18/2008). Contact Cordis special Customer Service at (800) 551-7683 for assistance.
Quantity in Commerce 11,893
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.
510(K) Database 510(K)s with Product Code = MCW and Original Applicant = LUMEND, INC.
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