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Terminated

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

FDA Recall Z-1186-2016 · Posted 2016-03-17

Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWC
Date Initiated2012-08-15
Date Terminated2017-05-26
Product Quantity1125 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide, VA/govt/military

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052601STOCKERT HEATER-COOLER SYSTEM 3TSorin Group Deutschland GmbH · 2006-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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