Z-0682-2017Class II

STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282...

Name: Z-0682-2017 STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282...
Creator: Sorin Group USA, Inc.
Published: 2014-08-01
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2014-08-01 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285... on 2014-08-01. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0682-2017
Classification: Class II
Status: Terminated
Initiated: 2014-08-01
Posted: 2016-12-01
Terminated: 2017-04-20
Recalling firm: LivaNova USA, Inc.
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
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
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).
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0682-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0682-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01

Product code DWC

K052601Class IIStockert Heater-Cooler System 3TSorin Group Deutschland GmbH / cleared 2006-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)