FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: 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.
- Recall number
- Z-1018-2016
- Recalling firm
- Sorin Group USA, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-01-19
- Posted
- not on file
- Terminated
- 2016-10-24
- Reason
- The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.
- Root cause
- Component design/selection
- Action
- A Safety Alert letter dated January 13, 2015 via registered mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check the communication of the Cuvette prior to initiating Cardiopulmonary Bypass (CPS). The Terumo Safety Alert did not request removal or return of the product. The instructions that Sarin has communicated to the customers is identical to the information from Terumo. Acknowledgement of the letter and understanding of the contents is required for all customer responses.
- Quantity
- 6859
- Distribution
- US Nationwide Distribution and Canada.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K881330"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28