Events

Recall of MULTI-FLEX DISPOSABLE BREATHING CIRCUIT

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
    25105
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-30
  • 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
    In-house confirmation that a low percentage of filters were found to have a small residual matter within and around the filter. the residual matter is very small and could make its way to the patient.

Device

MULTI-FLEX DISPOSABLE BREATHING CIRCUIT
  • Model / Serial
    Model Catalog: OL-618030-XX (Lot serial: see notice or contact mfr); Model Catalog: OL-609036-34 (Lot serial: see notice or contact mfr); Model Catalog: OL-040419-00 (Lot serial: see notice or contact mfr); Model Catalog: OL-040419-05 (Lot serial: see notice or contact mfr); Model Catalog: OL-544400-05 (Lot serial: see notice or contact mfr); Model Catalog: OL-608030-72 (Lot serial: see notice or contact mfr); Model Catalog: OL-608030-76 (Lot serial: see notice or contact mfr)
  • Product Description
    MULTI-FLEX DISP. BREATHING CIRCUIT
  • Manufacturer
    BOMIMED INC.

Manufacturer

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