Events

Recall of HISTOPAQUE 1077-1

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIGMA-ALDRICH CANADA CO..

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
    148546
  • Event Risk Class
    III
  • Event Initiated Date
    2009-09-21
  • 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
    Bacterial contamination (pseudomonas mendocina) in the affected device. the device is a cell separation media and in the reported instance was used to isolate stem cells from bone marrow specimens. the isolated cells were placed into cell culture for further testing and contamination was evident after 14 days of culture. the laboratory confirmed the source of contamination was the device.

Device

HISTOPAQUE 1077-1
  • Model / Serial
    Model Catalog: 1077-1 (Lot serial: 038K6170)
  • Product Description
    HISTOPAQUE 1077-1
  • Manufacturer
    SIGMA-ALDRICH CANADA CO.

Manufacturer

SIGMA-ALDRICH CANADA CO.
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Merck KGaA
  • Source
    HC