Events

Recall of TRIMA ACCEL LRS PLATELET + SAMPLER MULTIPLASMA RBC SET

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
    136806
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-12
  • 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
    Terumo bct records indicate you have received the above catalog number and product lots. the affected trima accel disposable sets catalog number 82408 were mislabeled as trima accel lrs platelet + 35 ml sampler multiplasma rbc sets despite having been manufactured with a 10 ml bacterial sampler.

Device

TRIMA ACCEL LRS PLATELET + SAMPLER MULTIPLASMA RBC SET
  • Model / Serial
    Model Catalog: 82408 (Lot serial: 1703011231); Model Catalog: 82408 (Lot serial: 1702231331)
  • Product Description
    TRIMA ACCEL LRS PLATELET + SAMPLER MULTIPLASM
  • Manufacturer
    TERUMO BCT (CANADA) INC.

Manufacturer

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