Class 2 Device Recall Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540

• Date Initiated by Firm: January 16, 2018
• Create Date: February 20, 2018
• Recall Status: Terminated on August 21, 2020
• Recall Number: Z-0645-2018
• Recall Event ID: 79058
• 510(K)Number: K936003
• Product Classification: Reservoir, blood, cardiopulmonary bypass - Product Code DTN
• Product: Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
• Code Information: All lots
• Recalling Firm/ Manufacturer: Medtronic Perfusion Systems; 7611 Northland Dr N; Brooklyn Park MN 55428-1088
• For Additional Information Contact: Joey Lomicky; 763-526-2494
• Manufacturer Reason for Recall: Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
• FDA Determined Cause: Process control
• Action: Medtronic sent an Urgent Medical Device Recall Letter dated January 16, 2018. Customer Actions: Please review your inventory for product affected by this issue. 1.) Immediately identify and quarantine all unused, non-expired, affected product in your inventory. 2.) Return all unused, affected product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 Option 4, or accessing My Orders and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. 3.) Complete the enclosed Customer Confirmation Certificate and scan and email to RS.CFQFCA@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For further questions, please call (763) 526-2494.
• Quantity in Commerce: 8644 units
• Distribution: Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.
• 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 = DTN