Events

Recall of Device Recall Level Sensor II Gel 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
    76458
  • Event Risk Class
    Class 2
  • Event Number
    Z-1459-2017
  • Event Initiated Date
    2017-02-20
  • Event Date Posted
    2017-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153247
  • 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
    Terumo cvs initiated a voluntary recall for the level sensor ii pads and level sensor gel pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
  • Action
    Terumo CVS initiated a voluntary recall by issuing a safety advisory for their Terumo Advanced Perfusion System 1-Level Sensor II Pads, and Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users. Customers are asked to do the following: 1. Review the Safety Advisory. 2. Assure that all users receive notice of this issue. 3. Confirm receipt of this Safety Advisory by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form. For questions contact Terumo CVS at 1-800-521-2818, Monday  Friday, 8 a.m.  6 p.m. ET. Any adverse events experienced with the use of this product, and/or quality problems should also be reported to the FDAs MedWatch Program: Phone: 1.800.FDA.1088 Fax: 1.800.FDA.0178, Web: www.fda.gov/medwatch/report.htm MedWatch Online Voluntary Reporting Form (mail to address on form): www.fda.gov/Safety/MedWatch/HowtoReport

Device

Device Recall Level Sensor II Gel Pads
  • Model / Serial
    Level Sensor II Gel Pads, Catalog No. 217390, UDI No: 00886799000519, Lot Numers Ranging from 782300 through 817488, Manufactured from 19-Nov-2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of: Mexico, AUSTRALIA, UNITED ARAB EMIRATES (UAE), Indonesia, Singapore, Taiwan, Thailand, COLOMBIA, CHILE, Vietnam, India, China, Malaysia, BELGIUM, Japan, CANADA
  • Product Description
    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads || Product Usage: || Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA