Events

Recall of Device Recall Terumo Cardiovascular Procedure 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
    72010
  • Event Risk Class
    Class 2
  • Event Number
    Z-2786-2015
  • Event Initiated Date
    2015-08-24
  • Event Date Posted
    2015-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139577
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code N/A
  • Reason
    Custom cardiovascular procedure kits contain recalled component medivators hph700 high performance hemoconcentrators.
  • Action
    Terumo CVS issued an Urgent Medical Device Recall Notice dated August 24, 2015, to consignees via express mail. The letter advised users to immediately quarantine affected Cardiovascular Procedure Kits and stop using the Hemocor HPH700 Hemoconcentrator within the kit. Replacement sterile, stand-alone Hemocor HPH700 Hemoconcentrators will accompany the letter so that users may replace the affected emoconcentrators at the point of use. The option of replacing the hemoconcentrator at the point of use is offered to facilitate imminently scheduled cardiopulmonary bypass procedures. Users are requested to return the unused hemoconcentrators to Terumo CVS. Alternatively, users may return the entire Cardiovascular Procedure Kit to Terumo CVS for replacement. Customers with questions were instructed to call 763-553-3348.

Device

Device Recall Terumo Cardiovascular Procedure Kit
  • Model / Serial
    Lot Number: TE06
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Product Description
    Terumo Custom Cardiovascular Procedure Kit Tubing Pack || P/N: 66041-1 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.
  • 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