Events

Recall of AQUESURE DISPOSABLE FILTERS

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

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
    69143
  • Event Risk Class
    II
  • Event Initiated Date
    2009-08-11
  • 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
    A customer could not get a co2 tracing while the anesthesia circuit was in use because the co2 port on the filter was blocked with the plastic mould. lot# listed are the affected anesthesia circuits.

Device

AQUESURE DISPOSABLE FILTERS
  • Model / Serial
    Model Catalog: (Lot serial: 042709); Model Catalog: (Lot serial: 042309); Model Catalog: (Lot serial: 042209)
  • Product Description
    AQUESURE DISPOSABLE FILTERS
  • Manufacturer
    BOMIMED INC.

Manufacturer

BOMIMED INC.
  • Manufacturer Address
    WINNIPEG
  • Manufacturer Parent Company (2017)
    Bomimed Inc
  • Source
    HC