Class 2 Device Recall Avanti Catheter Sheath Introducer

• Date Initiated by Firm: June 09, 2021
• Create Date: July 15, 2021
• Recall Status: Terminated on February 16, 2023
• Recall Number: Z-2079-2021
• Recall Event ID: 88112
• 510(K)Number: K970392
• Product Classification: Dilator, vessel, for percutaneous catheterization - Product Code DRE
• Product: Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
• Code Information: Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023
• FEI Number: 1016427
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 NW 60th Ave; Miami Lakes FL 33014-2802
• For Additional Information Contact: Cordis Customer Service; 800-327-7714 Ext. 1
• Manufacturer Reason for Recall: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
• FDA Determined Cause: Under Investigation by firm
• Action: A letter and Acknowledgement Form sent on June 8, 2021 to each account. Actions requested on your part: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to determine if you have any units from the affected lots in your possession. Identify and set aside any units from the identified lots in a manner that ensures that the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cardinalhealth.com 4) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 5) Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 1, Monday through Friday from 9:00 AM to 5:00 PM EDT. For questions related to assistance returning product or billing concerns please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00 AM to 8:00 PM EDT. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: GMB-CordisFieldAction@cardinalhealth.com or call (786) 313-2087.
• Quantity in Commerce: 680 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
• 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