Events

Recall of Device Recall Terumo Sarns Level Sensor II Pads

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
    46314
  • Event Risk Class
    Class 2
  • Event Number
    Z-0311-2009
  • Event Initiated Date
    2008-01-13
  • Event Date Posted
    2008-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67168
  • 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
    Level Sensor Pads - Product Code DTQ
  • Reason
    The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.
  • Action
    Consignees were notified via recall letter (Urgent Medical Device Removal letter) dated 2/13/08 and requested to report stocks on hand so that replacements could be sent.

Device

Device Recall Terumo Sarns Level Sensor II Pads
  • Model / Serial
    Lot Number 78925.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Japan, Saudi Arabia, Singapore and Yemen.
  • Product Description
    Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240. || Level Sensor pads are used to attach the level sensor || to the sides of a rigid reservoir.
  • 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