Devices

Device Recall Sorin Group Smart Perfusion Pack EPack

Model / Serial
Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distribution was made to one consignee in LA.
Product Description
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Manufacturer
LivaNova USA
1 Event
- Recall of Device Recall Sorin Group Smart Perfusion Pack EPack

Manufacturer

LivaNova USA

Manufacturer Address
LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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