Class 2 Device Recall S.M.A.R.T. Flex

• Date Initiated by Firm: October 01, 2021
• Create Date: November 12, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0217-2022
• Recall Event ID: 88821
• 510(K)Number: K121125
• Product Classification: Stents, drains and dilators for the biliary ducts - Product Code FGE
• Product: SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
• Code Information: Product Code: SF06120MB; Lot No. 266401
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 NW 60th Ave; Miami Lakes FL 33014-2802
• For Additional Information Contact: 786-313-2000
• Manufacturer Reason for Recall: There is a potential for distal tip dislodgement or separation.
• FDA Determined Cause: Process control
• Action: The firm, Cordis, sent an "Urgent MEDICAL DEVICE RECALL" letter dated 10/1/2021 to its consignees/customers: In the US: The letter and Acknowledgement Form was sent to the following two (2) individuals in each account: Materials Director, and Risk Manager. The delivered letter will be followed up as necessary by phone, until signed Acknowledgement is received, or best effort attempt has occurred. For Affiliate countries: A copy of the letter sent to the affiliates by email. Reconciliation within the country will be performed by the affiliate. A summary statement that the notification is completed is requested of the affiliate. Consignees are asked to do the following: 1) Read the Urgent Medical Device Recall letter. 2) Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession. If you discover that you do have units from the affected lots in your possession, identify and set aside any units from the identified lots in a manner that ensures 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. Maintain awareness of this notice until all affected product has been returned to Cordis. 6) 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 F
• Quantity in Commerce: 3 units
• Distribution: US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FGE and Original Applicant = FLEXIBLE STENTING SOLUTIONS, INC.