Events

Recall of AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STERIS CANADA INCORPORATED.

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
    51221
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-14
  • 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
    The amsco 400 steam sterilizers are designed for sterilization of heat and moisture stable materials used in healthcare facilities. the control board software is being revised to adjust the alarm set points such that the alarm is not erroneously triggered as the temperature of the sterilizer fluctuates during operation. when this alarm occurs the sterilizer locks up and cannot be used until serviced causing customer nuisance.

Device

AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER
  • Model / Serial
    Model Catalog: SR0101110011 (Lot serial: S/N: 033491207)
  • Product Description
    AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    HC