Events

Recall of AMSCO V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM

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
    108203
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-12
  • 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 become aware that the v-pro 60 software verifies expiration date of the vaprox sterilant upon completion of the sterilization cycle rather than prior to cycle initiation. verification of the vaprox expiration date at the end of the sterilization cycle will allow for the completion of one cycle with expired vaprox sterilant.

Device

AMSCO V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
  • Model / Serial
    Model Catalog: VP40002506 (Lot serial: s/n: 031351510); Model Catalog: VP40002406 (Lot serial: s/n: 031351510); Model Catalog: VP40002401 (Lot serial: s/n: 031351510); Model Catalog: VP40002506 (Lot serial: s/n: 032681519); Model Catalog: VP40002406 (Lot serial: s/n: 032681519); Model Catalog: VP40002401 (Lot serial: s/n: 032681519); Model Catalog: VP40002506 (Lot serial: s/n: 031481601); Model Catalog: VP40002406 (Lot serial: s/n: 031481601); Model Catalog: VP40002401 (Lot serial: s/n: 031481601); Model Catalog: VP40002506 (Lot serial: s/n: 033521520); Model Catalog: VP40002406 (Lot serial: s/n: 033521520); Model Catalog: VP40002401 (Lot serial: s/n: 033521520); Model Catalog: VP40002506 (Lot serial: s/n: 032321611); Model Catalog: VP40002406 (Lot serial: s/n: 032321611); Model Catalog: VP40002401 (Lot serial: s/n: 032321611); Model Catalog: VP40002506 (Lot serial: s/n: 032111549); Model Catalog: VP40002406 (Lot serial: s/n: 032111549); Model Catalog: VP40002401 (Lot serial: s/n: 032111549); Model Catalog:
  • Product Description
    AMSCO V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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