Devices

Device Recall OptiPack Smart Perfusion Pack

Model / Serial
Lot Numbers: 0924300054, 0924400026, and 0933400046.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
Product Description
Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
Manufacturer
Sorin Group USA, Inc.
1 Event
- Recall of Device Recall OptiPack Smart Perfusion Pack

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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