Devices

Device Recall Smart Perfusion Pack

Model / Serial
Lot Numbers: 0922900105, and 0923600037.
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
Smart Perfusion Pack, REF: 088500900, 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 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

29 devices with a similar name

Learn more about the data here

Device Recall Smart Perfusion Pack

Model / Serial
Lot Number: 0931600030.
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
, REF: 084500500, 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.

Device Recall Smart Perfusion Pack

Model / Serial
Lot Number: 0926600002
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
Smart Perfusion Pack, REF: 086500300, 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.

Device Recall Smart Perfusion Pack

Model / Serial
Lot Number: 0931600033
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
Smart Perfusion Pack, REF: 086500301, 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.

Device Recall Smart Perfusion Pack

Model / Serial
Lot Number: 0933600001
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
Smart Perfusion Pack, REF: 086500600, 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.

Device Recall Smart Perfusion Pack

Model / Serial
Lot Numbers: 0923000063, 0930100038, and 0923600036.
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
Smart Perfusion Pack, REF: 088500700, 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.

24 more

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)