Events

Recall of TERUMO 3T L. V. Control Valve

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
    59704
  • Event Risk Class
    Class 2
  • Event Number
    Z-3223-2011
  • Event Initiated Date
    2011-08-11
  • Event Date Posted
    2011-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103378
  • 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, Cpb Check Valve, Retrograde Flow, In-line - Product Code MJJ
  • Reason
    3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
  • Action
    Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers. The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm. For questions on this recall contact Terumo Customer Service at (734) 525-9580.

Device

TERUMO 3T L. V. Control Valve
  • Model / Serial
    Lot Numbers:  LN09  MA25  MD29  ME05  ME26  MF10  MF24  MG07  MH12  MK09
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including the states of FL and MI.
  • Product Description
    Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 || X-COATED 8:1 FX PACK || Item Number 73192 || Terumo Cardiovascular Systems Corp. || The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA