Events

Recall of Device Recall Terumo Custom Kit

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
    56037
  • Event Risk Class
    Class 2
  • Event Number
    Z-2152-2010
  • Event Initiated Date
    2010-06-08
  • Event Date Posted
    2010-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92490
  • 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 Procedure Kit - Product Code DTR
  • Reason
    Vent port may be occluded and prevent delivery of fluid.
  • Action
    Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.

Device

Device Recall Terumo Custom Kit
  • Model / Serial
    Lots: ME19, ME26
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution USA and Canada
  • Product Description
    Terumo Cardiovascular Procedure Kit Custom || 8:1 CARDIOPLEGIA SET || P/N 70608-01
  • 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