Class 2 Device Recall HeaterCooler 3T

• Date Initiated by Firm: August 15, 2012
• Date Posted: March 17, 2016
• Recall Status: Terminated on May 26, 2017
• Recall Number: Z-1186-2016
• Recall Event ID: 73352
• 510(K)Number: K052601
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
• Code Information: All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85
• FEI Number: 1718850
• Recalling Firm/ Manufacturer: Sorin Group USA, Inc.; 14401 W 65th Way; Arvada CO 80004-3503
• For Additional Information Contact: 303-467-6306
• Manufacturer Reason for Recall: On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
• FDA Determined Cause: Device Design
• Action: Sorin Germany, via Sorin Colorado, distributed an important information letter to its US customers on August 15, 2012 informing them about an update of the cleaning and infection procedure for the U.S. market that were included in Revision 12 of the IFU.
• Quantity in Commerce: 1125 units
• Distribution: Worldwide Distribution - US Nationwide, VA/govt/military
• 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 = DWC