Devices

Device Recall CDl H/S Cuvette Perfusion Pack or Smart Perfusion Pack

Model / Serial
Catalog Number 6922, 1/2 inch -lots TE27, TH06 and TK03 Catalog Number 6923, 3/8 inch - lots TE13, TE18, TG15, TH20 and TK17 b. Model Number(s): 020204612, 020208807, 020210805, 020211806, 020493806, 044002300, 044003200, 044004102, 044004700, 044010200, 044016900, 044017601, 044018700, 044019901, 044027700, 044035101, 075104103, 075104404, 020135802, 088511700, 084103204, 047000500, 046001601, 065255600, 066110500, 075203800, 627265002, 627304502, 084118101, 020277801, 075101900, 627309201, 075104800, 627138002, 627241801, 627305101, 627239301, 044006801, 627347601, 075203501, 627232601, 627123006, 627280901, 088523400, 627282602, 044022001, 627252001, 044020900, 627147304, 627147403, 627153904, 046003400, 627308201, 044013600, 088511801, 084515200, 044009000, 627282001, 044022000, 066109900, 627286901, 075201201, 075202000, 084103204, 088504901, 088508000, 088513300, 088513501, 627133104, 627139306, 627165604, 627166101, 627167301, 627167501, 627167601, 627167701, 627168001, 627168101, 627179903, 627190501, 627190801, 627197802, 627198001, 627198102, 627212201, 627297401, 047002300, 044000600, 627251001, 627254501, 627283501, 627283601, 627321201, 044003901, 088504400, 627198903, 627214003, 044028900, 627231801, 627240802, 627243501, 627243601, 627243701, 627244602, 627244701, 627246002, 627252001, 627256901, 627260701, 627262303, 627266301, 627269502, 627286802, 627286901, 627290001, 627303901, 627304901, 627336301, 627336402, 627343801, 627346601, 627346701, 627349401 Catalog Number 6924, 1/4 inch - lots TE20, TF11, TG01 , TG15, TH 13 and TH27
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution and Canada.
Product Description
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. || Product Usage: || Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.
Manufacturer
Sorin Group USA, Inc.
1 Event
- Recall of Device Recall CDl H/S Cuvette Perfusion Pack or Smart Perfusion Pack

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

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