Class 2 Device Recall AVANTI Catheter Sheath Introducer System

• Date Initiated by Firm: December 31, 2015
• Date Posted: March 15, 2016
• Recall Status: Terminated on August 25, 2016
• Recall Number: Z-1174-2016
• Recall Event ID: 73183
• 510(K)Number: K970392
• Product Classification: Dilator, vessel, for percutaneous catheterization - Product Code DRE
• Product: CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
• Code Information: Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 Nw 60th Ave; Miami Lakes FL 33014-2802
• For Additional Information Contact: Hal Baden; 786-313-2365
• Manufacturer Reason for Recall: Incorrect cannula of the sheath introducer (smaller than intended).
• FDA Determined Cause: Mixed-up of materials/components
• Action: The firm, Cordis, sent an 'Urgent MEDICAL DEVICE CORRECTION (Field Safety Notice) dated 12/31/2015 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Read the Description of the problem section carefully to fully understand the issue involved. 2) Check your inventory to determine if you have any remaining affected product in your possession. Check all storage and usage locations. The purpose is to identify the product, not to remove the product. 3) Keep a copy of this notice with any affected product. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis by fax to (908) 429-8287 Alternate fax (904) 928-5077. number or scan and email to MiamiFRA@its.jnj.com. 5) Share this letter with anyone who needs to be informed in your facility and in any facility where potentially affected devices may have been transferred. 6) Maintain awareness of this notice until all affected product has been consumed. If vessel dilator to sheath incompatibility is experienced, you can report the incident through the standard complaint process (1-800-327-7714 Option 3). For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730."
• Quantity in Commerce: 1,985 units
• Distribution: US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.
• 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 = DRE