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
    41521
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-04
  • 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
    Steris has identified the control board software in select amsco 400 units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. this may result in a procedure delay should the facility immediately require instruments from the cancelled processing cycle. if the processing cycle is interrupted the cycle should not be considered complete and the instruments should be reprocessed. steris has received no reports of procedure delays associated with the occurrence of these events.

Device

AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER
  • Model / Serial
    Model Catalog: SR010-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR020-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR310-XXXX-XXX (Lot serial: 03U11434); Model Catalog: SR320-XXXX-XXX (Lot serial: 033431406); Model Catalog: SR310-XXXX-XXX (Lot serial: 033431406); Model Catalog: SR320-XXXX-XXX (Lot serial: 03U11434); Model Catalog: SR310-XXXX-XXX (Lot serial: 083321409); Model Catalog: SR320-XXXX-XXX (Lot serial: 032831465); Model Catalog: SR310-XXXX-XXX (Lot serial: 032831465); Model Catalog: SR320-XXXX-XXX (Lot serial: 033021415); Model Catalog: SR310-XXXX-XXX (Lot serial: 033021415); Model Catalog: SR320-XXXX-XXX (Lot serial: 081251429); Model Catalog: SR310-XXXX-XXX (Lot serial: 081251429); Model Catalog: SR320-XXXX-XXX (Lot serial: 083321409); Model Catalog: SR212-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR222-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR232-XXXX-XXX (Lot serial: > 10 lot numbers contact m
  • 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