Events

Recall of AMBULATORY H-TRON V 100 INSULIN INFUSION PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by A & D INSTRUMENTS CANADA INC. DBA AUTO CONTROL MEDICAL.

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
    36183
  • Event Risk Class
    II
  • Event Initiated Date
    2001-04-20
  • 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
    Cases have been reported where water leaked into the pump and may have caused malfunction or over-infision. manufacturer can no longer make waterproof claims.

Device

AMBULATORY H-TRON V 100 INSULIN INFUSION PUMP

Manufacturer

A & D INSTRUMENTS CANADA INC. DBA AUTO CONTROL MEDICAL
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    A&D Company
  • Source
    HC