Devices

Device Recall Sorin Synthesis

Model / Serial
All Lots.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
1 Event
- Recall of Device Recall Sorin Synthesis

Manufacturer

Sorin Group USA, Inc.

Manufacturer Address
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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