Sorin Group USA, Inc. recalls Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Devic…
- Recall date
- August 15, 2012
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1186-2016
- FDA classification
- Class II
- Brand / firm
- Sorin Group USA, Inc.
- Sold / distributed
- Worldwide Distribution - US Nationwide, VA/govt/military
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Sorin Group USA, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Sorin Group USA, Inc.