Events

Recall of ASP AUTOMATIC ENDOSCOPE REPROCESSOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    25188
  • Event Risk Class
    III
  • Event Initiated Date
    2009-10-23
  • 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
    Advanced sterilization products (asp) is sending a letter to all automated endoscope reprocessor (aer) customers to reinforce the importance of properly setting the disinfectant cycle time when using the asp aer and to remind users to observe the illuminated temperature light during the cycle. asp has received user reports about improper times set for each disinfectant cycle.

Device

ASP AUTOMATIC ENDOSCOPE REPROCESSOR

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.