Class 2 Device Recall Protek Solo 24 Fr Venous Cannula Set

• Date Initiated by Firm: November 19, 2019
• Create Date: February 07, 2020
• Recall Status: Terminated on October 07, 2020
• Recall Number: Z-1106-2020
• Recall Event ID: 84611
• 510(K)Number: K162214
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
• Code Information: Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445, 141446/ (01)00814112020517(17)200825(11)190423(21)00141446, 141447/ (01)00814112020517(17)200825(11)190423(21)00141447, 141448/ (01)00814112020517(17)200825(11)190423(21)00141448, 141449/ (01)00814112020517(17)200825(11)190423(21)00141449, 141450/ (01)00814112020517(17)200825(11)190423(21)00141450, 141451/ (01)00814112020517(17)200825(11)190429(21)00141451, 141452/ (01)00814112020517(17)200825(11)190429(21)00141452, 141453/ (01)00814112020517(17)200825(11)190429(21)00141453, 141454/ (01)00814112020517(17)200825(11)190429(21)00141454, 141457/ (01)00814112020517(17)200825(11)190429(21)00141457 Expiration Date for all products - August 25, 2020
• Recalling Firm/ Manufacturer: Cardiac Assist, Inc; 240 Alpha Dr; Pittsburgh PA 15238-2906
• For Additional Information Contact: 412-963-7770 Ext. 227
• Manufacturer Reason for Recall: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
• FDA Determined Cause: Employee error
• Action: Initial communications were delivered verbally to quarantine devices starting November 19, 2019. Subsequently, on November 25, 2019 TandemLife issued Medical Device Correction notices to customers via letter 1st class mail (certified return receipt). Actions to be taken by the Customer 1. Check your inventory for the affected product listed within the notice 2. Discontinue use and Quarantine the product 2. Using the Response Form, please respond by email to USFSN@livanova.com to confirm appropriate action has been executed. 3. A replacement TandemLife ECLS Procedure Kit  V24/A17 (Reference 5740-2417) has already been shipped to your facility. Your TandemLife representative will contact you to organize the collection of the affected quarantined kit(s). 4. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be aware. If you have transferred any affected device to a third party, please communicate this information to them and inform TandemLife Quality Assurance Team at USFSN@livanova.com. For questions regarding this Medical Device Correction, please contact your TandemLife representative, or TandemLife Customer Quality at USFSN@livanova.com.
• Quantity in Commerce: 11 kits
• Distribution: US Nationwide distribution in the states of AZ, AL, ME, LA, PA.
• 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 = DWF