Events

Recall of Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves

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
    71196
  • Event Risk Class
    Class 2
  • Event Number
    Z-1828-2015
  • Event Initiated Date
    2015-05-06
  • Event Date Posted
    2015-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136456
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • Reason
    The overpressure safety valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. it is intended for use only on the venous side. there is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
  • Action
    Consignees were notified of the recall by phone beginning on 5/7/2015 and a Urgent Medical Device Recall letter, dated 5/7/2015. The letter identified the affected device, reason for recall, potential hazard, and correction. Customers were asked to review the notice and ensure that all users are aware of the issue. In addition, they are to confirm the quantity of procedure kits for return; and, complete and return the Customer Response Form. Customers can call Terumo CVS Customer Service at 1-800-521-2818 with questions.

Device

Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves
  • Model / Serial
    Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of MO and FL.
  • Product Description
    Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. || For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
  • 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