FDA-Device2016-03-23Class II
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
Sorin Group USA, Inc.
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide, VA/govt/military
Affected count
1125 units
Manufactured in
14401 W 65th Way, Arvada, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1186-2016Don't want to check this manually?
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