Events

Recall of Device Recall Terumo Cardiovascular Systems Kit XCoated Pump and Table Pack

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
    67925
  • Event Risk Class
    Class 2
  • Event Number
    Z-1465-2014
  • Event Initiated Date
    2014-03-28
  • Event Date Posted
    2014-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126616
  • 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 OEZ
  • Reason
    Incorrect customer notification label applied to the tyvek lid of this specific lot of terumo¿ cardiovascular procedure kits.
  • Action
    Terumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product.

Device

Device Recall Terumo Cardiovascular Systems Kit XCoated Pump and Table Pack
  • Model / Serial
    Lot Number: RA-27
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA
  • Product Description
    Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE || Catalog Number: 73431
  • 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