Class 3 Device Recall Introducer guide

• Date Initiated by Firm: May 05, 2004
• Date Posted: March 10, 2005
• Recall Status: Terminated 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: 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