Events

Recall of AMSCO V-PRO MAX 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
    107449
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-20
  • 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
    Steris has identified that v-pro 1 v-pro 1 plus and v-pro max sterilizers manufactured after january 1 2014 may not display the correct date as of february 29 2016. if users do not manually change the system date of the v-pro unit the unit's display and cycle printout will contain an incorrect date.Firm stated only vpro max is sold in canada.

Device

AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
  • Model / Serial
    Model Catalog: VP30003106 (Lot serial: >10 Lot numbers contact mfg); Model Catalog: VP30002106 (Lot serial: >10 Lot numbers contact mfg); Model Catalog: VP30002101 (Lot serial: >10 Lot numbers contact mfg)
  • Product Description
    AMSCO V-PROL MAX LOW TEMPERATURE STERILZiation system
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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