Events

Recall of Device Recall CDI 101

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    57189
  • Event Risk Class
    Class 2
  • Event Number
    Z-1943-2011
  • Event Initiated Date
    2010-11-01
  • Event Date Posted
    2011-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95558
  • 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
    In-line blood-gas sensor - Product Code DTY
  • Reason
    Inaccurate result. possibility for displayed values for potassium, co2, hematocrit, o2 saturation, ph, hemoglobin and other measured blood parameters to be inaccurate.
  • Action
    On 11/1/2010, Terumo sent "URGENT MEDICAL DEVICE CORRECTION" notices to Chief Perfusionist, Department of Cardiovascular Surgery or Director of Operating Room Services. The letter informed the consignees about the incidents of the CDI 100 and 101 displaying inaccurate values. The letter states that when a displayed value is significantly different from expectations based on the clinical situation, the user should verify the accuracy by independent means before treating. The letter included "Caution" stickers that were to be applied to the CDI system operators manual.

Device

Device Recall CDI 101
  • Model / Serial
    CDI 101 1070-1697
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, India, Colombia, Taiwan, Venezuela, Vietnam, Puerto Rico, Malaysia, Sri Lanka, Brazil, Indonesia, Pakistan, Chile, Germany, Hong Kong, Japan, AE, Singapore, Austria, Belgium and Thailand.
  • Product Description
    Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA