Events

Recall of Device Recall Sarns MP4 Cardioplegia Sets

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

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
    25714
  • Event Risk Class
    Class 2
  • Event Number
    Z-0664-03
  • Event Initiated Date
    2003-02-25
  • Event Date Posted
    2003-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26348
  • 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
    Heat-Exchanger, Cardiopulmonary Bypass - Product Code DTR
  • Reason
    There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
  • Action
    Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers.

Device

Device Recall Sarns MP4 Cardioplegia Sets

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd., Ann Arbor MI 48103
  • Source
    USFDA