Events

Recall of MANUAL JET VENTILATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INSTRUMENTATION INDUSTRIES 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
    71084
  • Event Risk Class
    III
  • Event Initiated Date
    2012-09-11
  • 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
    Cleaning recommendations as included in revision g of the directions of use are inconsistent with the 510(k) premarket notification as approved by the fda in 1999: the 510(k) documented the be 183-2 small bore tubing assembly as being for single patient use while the distributed copy states that the tubing assembly is reusable.

Device

MANUAL JET VENTILATOR
  • Model / Serial
    Model Catalog: BE 183-SU (Lot serial: >10 contact the manufacturer); Model Catalog: BE 183-SUR (Lot serial: >10 contact the manufacturer)
  • Product Description
    BE 183 Manual Jet Ventilators series
  • Manufacturer
    INSTRUMENTATION INDUSTRIES INC.

Manufacturer

INSTRUMENTATION INDUSTRIES INC.