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U.S. Department of Health and Human Services

Class 2 Device Recall HeaterCooler 3T

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  Class 2 Device Recall HeaterCooler 3T see related information
Date Initiated by Firm August 15, 2012
Date Posted March 17, 2016
Recall Status1 Terminated 3 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;
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 2		 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 and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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