Events

Recall of FEATHER-FLEX FLOW-INFLATING RESUSCITATOR BAG

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
    16493
  • Event Risk Class
    II
  • Event Initiated Date
    2013-09-06
  • 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
    There is a potential for the adjustable valve to leak which can cause a lack of pressure build up.

Device

FEATHER-FLEX FLOW-INFLATING RESUSCITATOR BAG
  • Model / Serial
    Model Catalog: OL-509903-19 (Lot serial: >10 contact manufacturer); Model Catalog: OL-509900-09 (Lot serial: >10 contact manufacturer); Model Catalog: OL-509903-20 (Lot serial: >10 contact manufacturer)
  • Product Description
    FEATHER FLEX FLOW INFLATING RESUSCITATOR BAG
  • Manufacturer
    BOMIMED INC.

Manufacturer

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