Z-1186-2016Class II

Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85...

Name: Z-1186-2016 Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85...
Creator: Sorin Group USA, Inc.
Published: 2012-08-15
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2012-08-15 / Terminated / root cause: design

FDA source

Sorin Group USA, Inc. began a recall of Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259 on 2012-08-15. FDA classified it as Class II and gives the reason as "On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1186-2016
Classification: Class II
Status: Terminated
Initiated: 2012-08-15
Posted: 2016-03-17
Terminated: 2017-05-26
Recalling firm: LivaNova USA, Inc.
Product: Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
Root cause tag: design
FDA root cause: Device Design
Action: Sorin Germany, via Sorin Colorado, distributed an important information letter to its US customers on August 15, 2012 informing them about an update of the cleaning and infection procedure for the U.S. market that were included in Revision 12 of the IFU.
Quantity in commerce: 1125 units
Distribution: Worldwide Distribution - US Nationwide, VA/govt/military
Product codes and lots: All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1186-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1186-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)