Events

Recall of MICROFIL COMPOSITE INSTRUMENT- GOLD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALMORE INTERNATIONAL 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
    21174
  • Event Risk Class
    III
  • Event Initiated Date
    2017-05-16
  • 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
    Almore international inc. is voluntarily recalling the following microfil composite instruments that were shipped between january 1 2017 and march 17 2017. microfil composite instruments in these shipments contained the sterile symbol on their packaging label insertsindicating that the products are sold as sterile devices. these products are not sterile. these devices are intended to be sterile prior to use but they were distributed in packaging with a sterile symbol. we are concerned customers could misinterpret this labeling and assume this device is sterile.

Device

MICROFIL COMPOSITE INSTRUMENT- GOLD
  • Model / Serial
    Model Catalog: 96041 (Lot serial: 201609); Model Catalog: 96041 (Lot serial: 082015); Model Catalog: 96041 (Lot serial: 12983); Model Catalog: 96041 (Lot serial: NOT APPLICABLE); Model Catalog: 96041 (Lot serial: 01012017); Model Catalog: 96044 (Lot serial: NOT APPLICABLE); Model Catalog: 96044 (Lot serial: 12983); Model Catalog: 96044 (Lot serial: 082015); Model Catalog: 96044 (Lot serial: 201609); Model Catalog: 96044 (Lot serial: 01012017); Model Catalog: 96042 (Lot serial: 201609); Model Catalog: 96042 (Lot serial: 01012017); Model Catalog: 96042 (Lot serial: 12983); Model Catalog: 96042 (Lot serial: 082015); Model Catalog: 96042 (Lot serial: NOT APPLICABLE)
  • Product Description
    #96041- Gold Microfil;#96044- SET OF 3 MICROFIL (GOLD GREEN BLUE);#96042- GREEN MICROFIL;MICROFIL COMPOSITE INSTRUMENT- GOLD;MICROFIL COMPOSITE INSTRUMENT- GOLD GREEN BLUE;MICROFIL COMPOSITE INSTRUMENT- GREEN
  • Manufacturer
    ALMORE INTERNATIONAL INC.

Manufacturer

ALMORE INTERNATIONAL INC.