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U.S. Department of Health and Human Services

Class 3 Device Recall Introducer guide

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  Class 3 Device Recall Introducer guide see related information
Date Initiated by Firm May 05, 2004
Date Posted March 10, 2005
Recall Status1 Terminated 3 on November 21, 2008
Recall Number Z-0588-05
Recall Event ID 29574
510(K)Number K001136  
Product Classification Catheter, Percutaneous - Product Code DQY
Product Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
Code Information Lot # L0104244
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
Manufacturer Reason
for Recall		 The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
FDA Determined
Cause 2		 Other
Action A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion.
Quantity in Commerce 40
Distribution Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa and the Netherlands.
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 = DQY and Original Applicant = CORDIS CORP.
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