Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73126
  • Event Risk Class
    Class 3
  • Event Number
    Z-1018-2016
  • Event Initiated Date
    2016-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143117
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 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.
  • 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.

Device

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.

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