Events

Recall of CUSTOM STERILE CATARACT PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOURCE MEDICAL CORPORATION.

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
    50982
  • Event Risk Class
    II
  • Event Initiated Date
    2007-11-21
  • 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
    Possibility of no fluid or restricted fluid flow when using cannulas from affected lots.

Device

CUSTOM STERILE CATARACT PACK
  • Model / Serial
    Model Catalog: SEY30CAXXX (Lot serial: 7177806 and 7088657); Model Catalog: SEY30CAXXX (Lot serial: 7178690 and 7088612)
  • Product Description
    bd visitec nucleus hydrodissector
  • Manufacturer
    SOURCE MEDICAL CORPORATION

Manufacturer

SOURCE MEDICAL CORPORATION
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC