Devices

Device Recall Smart Perfusion Pack

Model / Serial
Lot Numbers: 0923100043 and 0923600038.
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: 088501100, 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, NEONATE/PEDIATRIC

Model / Serial
Lot Number 1709500117
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
Manufacturer
Sorin Group USA, Inc.

Device Recall SMART PERFUSION PACK, NEONATE/PEDIATRIC

Model / Serial
Lot Numbers: 1620000113, 1622400049, 1624300090, 1631200072, 1632100059, 1632800059, 1633300054, 1705100057, 1711500053
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
Manufacturer
Sorin Group USA, Inc.

Device Recall SMART PERFUSION PACK, TOTAL VISION SYSTEMSMA

Model / Serial
Lot Numbers: 1622100055, 1625200039, 1629800049
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
Manufacturer
Sorin Group USA, Inc.

Device Recall SMART PERFUSION PACK, INSPIRE 8S

Model / Serial
Lot Number 1717300032
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
Manufacturer
Sorin Group USA, Inc.

Device Recall SMART PERFUSION PACK, SMART 1/4" PEDS PACK

Model / Serial
Lot Numbers: 1621400045, 1628600043
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Manufacturer
Sorin Group USA, Inc.

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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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