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Recall Observatory FDA recall evidence

Device 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

Z-0682-2017

August 01, 2014

Class II

Product summary

Firm
Sorin Group USA, Inc.
Event
Event 75573
Status
Terminated
Classification
Class II
Quantity
1,618 units in the US; 129 units outside of US
Official record key
device-enforcement:Z-0682-2017

Official wording

Reason: 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).

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).