Events

Recall of AOSEPT STARTER KIT WITH SALINE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CIBA VISION CANADA 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
    64583
  • Event Risk Class
    II
  • Event Initiated Date
    2001-11-16
  • 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
    Note*** firm had scrapped 34 kits on or before the recall.

Device

AOSEPT STARTER KIT WITH SALINE
  • Model / Serial
    Model Catalog: (Lot serial: DEV. LIC. # 9773); Model Catalog: (Lot serial: LOT. U0110 EXP.2002/10); Model Catalog: (Lot serial: DEV. LIC. # 5289); Model Catalog: (Lot serial: LOT 12006 EXP.2002/09)
  • Product Description
    AOSEPT STARTER KITS
  • Manufacturer
    CIBA VISION CANADA INC.

Manufacturer

CIBA VISION CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC