Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HeaterCooler 3T

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall HeaterCooler 3T see related information
Date Initiated by Firm August 01, 2014
Date Posted December 01, 2016
Recall Status1 Terminated 3 on April 20, 2017
Recall Number Z-0682-2017
Recall Event ID 75573
510(K)Number K052601  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz
The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact Joan Ceasar
303-467-6306
Manufacturer Reason
for Recall		 On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).
FDA Determined
Cause 2		 Material/Component Contamination
Action Sorin Group sent an Important Information letter dated August 1, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by then consignee. Consignees were instructed to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU). Consignees with questions were instructed to call 303-467-6527 or 303-467-6503. For questions regarding this recall call 281-228-7260.
Quantity in Commerce 1,618 units in the US; 129 units outside of US
Distribution Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.
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
-
-