Events

Recall of J6 CENTRIFUGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    105685
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-17
  • 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
    Blood bag cups (pn: 363651) designed for the js-4.2sm (pn348394) and js-4.2sma rotors (pn366670) that are damaged may break during centrifugation potentially releasing biohazardous material into the chamber of the centrifuge.

Device

J6 CENTRIFUGE
  • Model / Serial
    Model Catalog: 363651 (Lot serial: N/A)
  • Product Description
    BLOOD BAG CUP USED IN MODEL J6 SERIES CENTRIFUGES (J6-HC J6-MC AND J6-MI)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.