Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1186-2016 — 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

U.S. FDA — Device Enforcement · United States · 2012-08-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1186-2016
Date of alert
2012-08-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sorin Group USA, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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