Events

Recall of AMSCO EVOLUTION PREVACUUM 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
    66599
  • Event Risk Class
    III
  • Event Initiated Date
    2012-04-11
  • 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
    Through customer feedback and field service experience steris has learned that evolution transfer carriage users may experience premature wear of loading car components. users may also experience difficulty in loading and unloading the evolution sterilizer due to the carriage not performing as intended.

Device

AMSCO EVOLUTION PREVACUUM STEAM STERILIZER
  • Model / Serial
    Model Catalog: M4011090 (Lot serial: 030400905 to 030381235); Model Catalog: M4011085 (Lot serial: 030400905 to 030381235); Model Catalog: M4011084 (Lot serial: 030400905 to 030381235); Model Catalog: M4012098 (Lot serial: 030400905 to 030381235); Model Catalog: M4012097 (Lot serial: 030400905 to 030381235); Model Catalog: M4011085 (Lot serial: 030400905 thru 030381235); Model Catalog: M4011090 (Lot serial: 030400905 thru 030381235); Model Catalog: M4012097 (Lot serial: 030400905 thru 030381235); Model Catalog: M4011084 (Lot serial: 030400905 thru 030381235); Model Catalog: M4012098 (Lot serial: 030400905 thru 030381235)
  • Product Description
    EVOLUTION TRANSFER CARRIAGE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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