Events

Recall of ADIPOSE TRANSFER SYSTEM W/ CANNULAE

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
    75529
  • Event Risk Class
    III
  • Event Initiated Date
    2016-11-21
  • 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
    The procedure packs have been mislabelled. three catalog numbers were involved in the mislabeling but only one of the catalog numbers affected are licensed and sold in canada.

Device

ADIPOSE TRANSFER SYSTEM W/ CANNULAE
  • Model / Serial
    Model Catalog: (Lot serial: 08Z9901); Model Catalog: (Lot serial: 08Z9933)
  • Product Description
    Harvest Terumo BCT- AdiPrep Concentration System
  • Manufacturer
    TERUMO BCT INC.

Manufacturer

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