Class 2 Device Recall Stryker Sustainability Solutions

• Date Initiated by Firm: April 28, 2016
• Create Date: May 23, 2016
• Recall Status: Terminated on June 29, 2016
• Recall Number: Z-1708-2016
• Recall Event ID: 73983
• 510(K)Number: K012708
• Product Classification: Catheter, recording, electrode, reprocessed - Product Code NLH
• Product: Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
• Code Information: Catalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017 Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017
• FEI Number: 3009350690
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: 888-888-3433
• Manufacturer Reason for Recall: Mislabeled for size
• FDA Determined Cause: Under Investigation by firm
• Action: The firm sent out customer notification letters on 04/28/16. Customers are instructed to discontinue the use of affected lots of recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to facility is enclosed. Please complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in your inventory. This form needs to be completed even if no affected product is found. Please return the completed and signed Recall Effectiveness Check Form to your local Stryker Sustainability Sales Representative or email to SSSPFA@stryker.com or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. On 05/12/16 the firm sent out a clarification letter to emphasize that use of affected lots of product should be discontinued. In addition, SSS would like to note that, use of devices larger than expected may result in excess force applied to the blood vessel. The risk to the patient can vary from a prolongation in procedure time, vessel rupture, organ damage or other unforeseen consequences. Some of these injuries may require surgery or other procedures to remedy. Any questions contact the Stryker Sustainability Solutions Sales Representative or Regulatory Affairs.
• Quantity in Commerce: 18 devices
• Distribution: Distributed in the state of NY and 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 = NLH