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Devices
Device Recall SMART PERFUSION PACK, SMART VENOUS VACUUM
Model / Serial
Lot numbers: 1620200038, 1621700037, 1622800048, 1623100036, 1623700036, 1625700047, 1627900048, 1630500054, 1630600077, 1631900048, 1632700043, 1633500024, 1701000056, 1701600055, 1701800042 1704500037, 1705300070, 1706100042, 1707600055, 1706600103, 1707900056, 1708900035, 1710700038, 1712400062, 1713600042, 1714400058, 1715200088, 1715800067
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
Manufacturer
Sorin Group USA, Inc.
1 Event
Recall of Device Recall SMART PERFUSION PACK, SMART VENOUS VACUUM
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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
Language
English
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