Events

Recall of DISINFECTION SYSTEM - 208 VOLTAGE

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
    92384
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-01
  • 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 has determined that a limited number of evotech endoscope cleaner and reprocessor systems manufactured between 2011 and 2012 did not receive sufficient high potential dc voltage testing. this test is one of a series of tests required to verify that all electrical components within the system are performing as intended after systems are fully assembled.

Device

DISINFECTION SYSTEM - 208 VOLTAGE
  • Model / Serial
    Model Catalog: 50014-102 (Lot serial: 5041120176); Model Catalog: 50014-101 (Lot serial: 5041120176); Model Catalog: 50014-102 (Lot serial: 5041120168); Model Catalog: 50014-101 (Lot serial: 5041120168); Model Catalog: 50014-102 (Lot serial: 5041110160); Model Catalog: 50014-101 (Lot serial: 5041110160); Model Catalog: 50014-102 (Lot serial: 5041110159); Model Catalog: 50014-101 (Lot serial: 5041110159); Model Catalog: 50014-102 (Lot serial: 5041110126); Model Catalog: 50014-101 (Lot serial: 5041110126); Model Catalog: 50014-102 (Lot serial: 5041110125); Model Catalog: 50014-101 (Lot serial: 5041110125); Model Catalog: 50014-102 (Lot serial: 5041110124); Model Catalog: 50014-101 (Lot serial: 5041110124); Model Catalog: 50014-102 (Lot serial: 5041110122); Model Catalog: 50014-101 (Lot serial: 5041110122)
  • Product Description
    EVOTECH ENDOSCOPE CLEANER & REPROCESSOR
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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