Events

Recall of DIAL REGULATORS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PRECISION MEDICAL 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
    72854
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-27
  • 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 flow rate labels on lot numbers 072215 or 072315 may not be on correctly. please check your inventory of these regulators to verify the liter labels are placed on correctly. when correct rotated fully counterclockwise the label should be in the off position in relation to the indicator above.

Device

DIAL REGULATORS
  • Model / Serial
    Model Catalog: 1600D (Lot serial: 072215); Model Catalog: 1600D (Lot serial: 072315)
  • Product Description
    DIAL REGULATORS
  • Manufacturer
    PRECISION MEDICAL INC.

Manufacturer

PRECISION MEDICAL INC.