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Devices
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.
1 Event
Recall of Device Recall SMART PERFUSION PACK, NEONATE/PEDIATRIC
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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
One device with a similar name
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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.
Language
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