Events

Recall of BLOM-SINGER ADJUSTABLE TRACHEOSTOMA VALVE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by A & D INSTRUMENTS CANADA INC. DBA AUTO CONTROL MEDICAL.

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
    63108
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-02
  • 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
    The body component of the device in the noted lots is missing from the packaging. the product cannot be used without this piece. there are no potential health hazards with this problem.

Device

BLOM-SINGER ADJUSTABLE TRACHEOSTOMA VALVE
  • Model / Serial
    Model Catalog: BE8025H-R3 (Lot serial: 1059222); Model Catalog: BE8025H (Lot serial: 1059222); Model Catalog: BE8025H-R3 (Lot serial: 1057919); Model Catalog: BE8025H (Lot serial: 1057919); Model Catalog: BE8025H-R3 (Lot serial: 1057760); Model Catalog: BE8025H (Lot serial: 1057760)
  • Product Description
    BLOM-SINGER ADJUSTABLE TRACHEOSTOMA VALVE II
  • Manufacturer
    A & D INSTRUMENTS CANADA INC. DBA AUTO CONTROL MEDICAL

Manufacturer

A & D INSTRUMENTS CANADA INC. DBA AUTO CONTROL MEDICAL
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    A&D Company
  • Source
    HC