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
FDA Recall Z-0682-2017 · Posted 2016-12-01
Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWC
Date Initiated2014-08-01
Date Terminated2017-04-20
Product Quantity1,618 units in the US; 129 units outside of US
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).
Firm 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.
Root Cause
Material/Component Contamination
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.