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Sorin Group USA, Inc. recalls ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler
Recalled December 7, 2016 · FDA recall Z-0682-2017 · Sorin Group USA
Hazard
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 Class II
Units
1,618 units in the US; 129 units outside of US
Sold at
Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.
Description
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 ).
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
Manufacturer(s)
Sorin Group USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →