Recall Z-1186-2016— Sorin Group USA, Inc.

Name: FDA recall Z-1186-2016
Creator: U.S. Food and Drug Administration
Published: 2012-08-15

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2012-08-15, terminated 2017-05-26. It names one FDA 510(k) clearance: K052601. 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. Reason: 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..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-15
Terminated: 2017-05-26
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K052601 — STOCKERT HEATER-COOLER SYSTEM 3TSorin Group Deutschland GmbH·cleared 2006-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.