Sorin Group USA, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1186-2016)

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:

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 Classification:

Class II

Date Initiated: August 15, 2012

Date Posted: March 23, 2016

Recall Number: Z-1186-2016

Event ID: 73352

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.

Status: Terminated

Product Quantity: 1125 units

Code Information:

All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;

Distribution Pattern:

Worldwide Distribution - US Nationwide, VA/govt/military

Voluntary or Mandated:

Voluntary: Firm initiated