Events

Recall of Terumo Sarns Level Detect II Mount 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
    59455
  • Event Risk Class
    Class 2
  • Event Number
    Z-3176-2011
  • Event Initiated Date
    2011-08-12
  • Event Date Posted
    2011-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102829
  • 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
    Cardiovascular Sensor Pads - Product Code KRI
  • Reason
    Level sensor ii mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.
  • Action
    Terumo Cardiovascular Systems Corp. sent an "Urgent Medical Device Removal" notice dated August 10, 2011 to all affected customers. The notice instructs customers to discard all remaining level sensor pads that do not have an expiration date on the package, and notify Terumo of the number of affected pads via a response form. Terumo will replace recalled product. For questions on this recall call Terumo Customer Service at (800) 521-2818, 8 am-6 pm EST.

Device

Terumo Sarns Level Detect II Mount Pads
  • Model / Serial
    Product code: 195240 Batch Numbers 616814, 618558, 619369, and 619396.  Lot codes: 123360, 129471, 29371-1, 29371-2, 36281, 40406, 42244, 44233, 49385, 51662, 56778, 58289, 61740, 64408, 68194, 70674, 75069, 78925, 80039, 82191, 86889, 90106, 90332, 91899, 98907, 99493, 99495, 101524, 105072, and 105808.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.
  • Product Description
    Terumo Sarns Level Sensor II Pads. || Terumo Cardiovascular Systems Corporation. || Used to attach level sensors to the sides of the venous 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