Events

Recall of Device Recall Sarns Terumo perfusion

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
    36962
  • Event Risk Class
    Class 2
  • Event Number
    Z-0617-2007
  • Event Initiated Date
    2006-12-12
  • Event Date Posted
    2007-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49678
  • 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
    perfusion system - Product Code KFM
  • Reason
    Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
  • Action
    Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.

Device

Device Recall Sarns Terumo perfusion
  • Model / Serial
    Serial numbers 0001 through 2696.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Woldwide, including USA, Canada, and Mexico
  • Product Description
    Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA