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Devices
Device Recall SMART PERFUSION PACK, SMART 3/16" PEDS PACK
Model / Serial
Lot Numbers: 1621400046, 1623100048, 1706100049, 1706500064
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
Manufacturer
Sorin Group USA, Inc.
1 Event
Recall of Device Recall SMART PERFUSION PACK, SMART 3/16" PEDS PACK
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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
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