Class 2 Device Recall Cordis PRECIS (R) Rx Nitinol Stent System

• Date Initiated by Firm: May 04, 2016
• Create Date: June 10, 2016
• Recall Status: Terminated on July 26, 2019
• Recall Number: Z-1947-2016
• Recall Event ID: 74097
• PMA Number: P030047
• Product Classification: Stent, carotid - Product Code NIM
• Product: Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
• Code Information: Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243.
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 Nw 60th Ave; Miami Lakes FL 33014-2802
• For Additional Information Contact: Hal Baden; 786-313-2000
• Manufacturer Reason for Recall: Inability to deploy the stent or partial stent deployment.
• FDA Determined Cause: Component design/selection
• Action: Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 2016, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowledgement Forms if your facility received affected product at both a legacy Ship-To account number and a Cardinal Health Ship¿ To account number at the same address. In that scenario, please sign and return both forms. 3) Return all affected products to the address listed on the form, with reference to Return Authorization Number ( i.e. RA #)#which is listed on the form. Replacement devices will be shipped after the affected product is returned. Consigned Inventory will also be replaced after the product is returned and an analysis of SKU mix needed to properly support the customer is conducted. 4) Share this letter with others in your facility who need to be made aware of this recall, including the areas in some facilities where these products are frequently used (see list above) Contact any other facilities that have been provided with units of affected lots. Maintain awareness of this notice until all affected product has been returned to Cordis. 5) Keep a copy of this notice with any affected product until returned. For questions related to assistance returning product or billing concerns or questions please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00AM to 8:00 PM EDT.
• Quantity in Commerce: 4,400 units in US; 3,100 units to Foreign Countries
• Distribution: NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
• 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.

• PMA Database: PMAs with Product Code = NIM and Original Applicant = Cordis US Corporation