Reported Dec 7, 2016 · Terminated
ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282,…
Sorin Group USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | ST¿CKERT HeaterCooler System 3T |
| 2 | Item Number 160281, HeaterCooler 3T, 240V/60Hz |
| 3 | Item Number 160282, HeaterCooler 3T, 208V/60Hz |
| 4 | Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours |
- Lot codes and dates
- All Serial Numbers
- Amount recalled
- 1,618 units in the US; 129 units outside of US
Where it was sold
- Nationwide
- PR
Why it was recalled
On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use ( IFU ).
This product could cause temporary or reversible health problems — stop using it.
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