Events

Recall of COBE TRIMA BLOOD COLLECTION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO BCT (CANADA) 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
    132630
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-08
  • 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
    Defects may occur during the manufacturing of trima accel tubing sets. it was found during assembly of the ac/draw/return manifold the automated equipment may improperly insert the return line tubing into the manifold in such a way that the tubing maybe bent.

Device

COBE TRIMA BLOOD COLLECTION SYSTEM
  • Model / Serial
    Model Catalog: 80700 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80450 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80500 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80490 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-450 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80449 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80440 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80400 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-550 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-500 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-400 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80550 (Lot serial: CONTACT MANUFACTURER FOR LOTS)
  • Product Description
    COBE TRIMA BLOOD COLLECTION SYSTEM
  • Manufacturer
    TERUMO BCT (CANADA) INC.

Manufacturer

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