Events

Recall of COBE SPECTRA BLOOD COMPONENT SEPERATOR SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO BCT INC..

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
    77882
  • Event Risk Class
    I
  • Event Initiated Date
    2007-12-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Leak may occur near spike port on secondary platelet collect bag. leak is very small and occurs consistently in same location both during run as well as post-collection. may result in product contamination.

Device

COBE SPECTRA BLOOD COMPONENT SEPERATOR SYSTEM
  • Model / Serial
    Model Catalog: 777003-005 (Lot serial: >10 numbers contact manufactr); Model Catalog: 777003-215 (Lot serial: >10 numbers contact manufactr); Model Catalog: 777800-400 (Lot serial: >10 numbers contact manufactr)
  • Product Description
    COBE Spectra Tubing Set
  • Manufacturer
    TERUMO BCT INC.

Manufacturer

TERUMO BCT INC.
  • Manufacturer Address
    LAKEWOOD
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    HC