| Class 2 Device Recall HeaterCooler 3T | |
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
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Product | STCKERT 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 Stckert 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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DWC
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