Class 2 Device Recall Terumo Advanced Perfusion System 1

• Date Initiated by Firm: August 25, 2020
• Create Date: September 12, 2020
• Recall Status: Terminated on January 29, 2021
• Recall Number: Z-2961-2020
• Recall Event ID: 86338
• 510(K)Number: K172220
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
• Code Information: UDI: 00886799000052; Serial Numbers: 20019 20020
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• Manufacturer Reason for Recall: Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
• FDA Determined Cause: Employee error
• Action: Urgent Medical Device Removal notification letters dated 8/25/20 were sent to customers. Terumo CVS is removing the affected ABD sensors from the field. A Terumo Associate will contact all affected customers to coordinate the shipment of a replacement device and subsequent return of the affected unit. The replacement ABD sensor supplied by Terumo CVS will be part of a kit containing a cable and a bracket which are not affected by this removal. The cable and the bracket do not require replacement. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Review Product Return instructions when provided by separate email communication. Tracking information on replacement device will be provided as well as a Return Goods Authorization (RGA) number to facilitate the return of the affected device., 4. Once the replacement shipment has been received, remove the affected ABD sensor and replace it with the new ABD sensor provided by Terumo CVS. 5. Return affected ABD sensor using the packing container and shipping materials received with the replacement ABD device. Please mark the RGA number on the outside of the box. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday  Friday, 8 a.m.  6 p.m. ET Recall Fax: 1.734.741.6149 Review this Medical Device Correction and assure that all users have received notice of this issue. A Terumo Associate will contact all affected customers to coordinate the shipment of a replacement ABD sensor and subsequent return of the affected unit. Terumo CVS recommends that you continue using your ABD sensor while waiting for a replacement. If you experience an ABD sensor failure, or have questions, contact Terumo CVS Customer Service: 800.521
• Quantity in Commerce: 2
• Distribution: Worldwide distribution - US Nationwide distribution.
• 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 = DTQ