Devices

Device Recall Sorin Group

Model / Serial
All Lots.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004 (utilizing oxygenators 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 Group

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

One device with a similar name

Learn more about the data here

Device Recall Sorin Group Smart Perfusion Pack EPack

Model / Serial
Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distribution was made to one consignee in LA.
Product Description
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Manufacturer
LivaNova USA

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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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