Events

Recall of Terumo Backplate Replacement CXFVR 1500 Holder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems 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
    63225
  • Event Risk Class
    Class 2
  • Event Number
    Z-0071-2013
  • Event Initiated Date
    2009-10-02
  • Event Date Posted
    2012-10-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113066
  • 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
    Accessory equipment, cardiopulmonary bypass - Product Code KRI
  • Reason
    Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. the devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (see location of supports as # 7 and # 8 on backplate attachment). the backplates were manufactured as described in manufacturing instructions a.
  • Action
    The firm, Terumo, interviewed the Sr. Product Manager from the Marketing Department of the company on August 29, 2012. The interview included the description of the product, problem and action taken. Replacement connectors were provided to users and all units were corrected. If you have any questions, call 734-663-4145 or Manager, Regulatory Affairs at 734-741-5576.

Device

Terumo Backplate Replacement CXFVR 1500 Holder
  • Model / Serial
    No lot/serial number; Catalog number: PN 816280
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.
  • Product Description
    Terumo Backplate Replacement CXFVR 1500 Holder || The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA