Events

Recall of Device Recall MYO Cardioplegia Delivery Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular 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
    56413
  • Event Risk Class
    Class 2
  • Event Number
    Z-2610-2010
  • Event Initiated Date
    2010-06-08
  • Event Date Posted
    2010-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93571
  • 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
    Cardioplegia Delivery Tube Sets - Product Code DTR
  • Reason
    Medical device vent port may be occluded and prevent delivery of priming fluid.
  • Action
    Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.

Device

Device Recall MYO Cardioplegia Delivery Sets
  • Model / Serial
    Lot numbers: MD15, MD15A, MD22, MD29, MD29A, ME19, and  ME26A
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were distributed nationwide.
  • Product Description
    Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375
  • Manufacturer
    Terumo Cardiovascular Corporation

Manufacturer

Terumo Cardiovascular Corporation
  • Manufacturer Address
    Terumo Cardiovascular Corporation, 125 Blue Ball Road, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA