Class 2 Device Recall Integrated Cardioplegia Delivery Sets

• Date Initiated by Firm: March 01, 2011
• Date Posted: October 31, 2014
• Recall Status: Terminated on November 06, 2014
• Recall Number: Z-0157-2015
• Recall Event ID: 58185
• 510(K)Number: K810079
• Product Classification: Accessory equipment, cardiopulmonary bypass - Product Code KRI
• Product: Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity
• Code Information: Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 28 Howe St; Ashland MA 01721-1305
• For Additional Information Contact: Same; 508-231-2400
• Manufacturer Reason for Recall: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
• FDA Determined Cause: Device Design
• Action: Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.
• Quantity in Commerce: 165 units
• Distribution: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
• 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 = KRI