Events

Recall of Device Recall Sarns" Modular Perfusion System 8000

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
    62732
  • Event Risk Class
    Class 3
  • Event Number
    Z-2218-2012
  • Event Initiated Date
    2012-06-20
  • Event Date Posted
    2012-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111539
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    During a retrospective review of complaint events, tcvs identified on 06/15/12 that three (3) sarns" system 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. the mislabeling was identified in january 2007 a set up process of the automark label printer. all units were corrected in the field in marc.
  • Action
    Terumo field correction/service records were completed in 2007 and all affected units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. For questions about this report call 734-741-6056.

Device

Device Recall Sarns" Modular Perfusion System 8000
  • Model / Serial
    catalog number: 16401 and serial number: 2001, 2002, and 2003.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - including the state of New York
  • Product Description
    System 8000 Base || Product Usage: || The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • 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