Sorin Group USA, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0682-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 1, 2014

Date Posted: December 7, 2016

Recall Number: Z-0682-2017

Event ID: 75573

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).

Status: Terminated

Product Quantity: 1,618 units in the US; 129 units outside of US

Code Information:

All Serial Numbers

Distribution Pattern:

Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.

Voluntary or Mandated:

Voluntary: Firm initiated