Devices

Device Recall Stckert S5 System

Model / Serial
Item No.: 48-30-00 Serial No: 28E24640, 28E24651, 28E24642, 28E24674, 28E24657, 28E24652, 28E24671, 28E24675, 28E24676, 28E24678, 28E24670 Item No 48-40-00 Serial No: 28E24644, 28E24641, 28E24648, 28E24661, 28E24643, 28E24650, 28E24677, 28E24659, 28E24658, 28E24672, 28E24666, 28E24660, 28E24665, 28E24645, 28E24646, 28E24667, 28E24668, 28E24669, 28E24679 Item No 48-50-00 Serial No: 28E24647, 28E24663, 28E24673, 28E24664 Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.
Product Description
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console || Product Usage: || The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
Manufacturer
Sorin Group USA, Inc.
1 Event
- Recall of Device Recall Stckert S5 System

Manufacturer

Sorin Group USA, Inc.

Manufacturer Address
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
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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