Events

Recall of CATARACT PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    38435
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-22
  • 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
    Cardinal health has been informed by beaver visitec of a field safety notice for the beaver xstar safety knives (contained in the cardinal health kits). the knives feature an integrated retractable safety shield to minimize the risk of accidental surgical blade injuries during handling. beaver visitec has received 20 complaints in which the protective shield was retracted thereby exposing the blade. the knives are provided in a tyvek covered tray and customers are advised prior to opening the tyvek tray to visually confirm that the plastic shield is not retracted. if the shield is in the retracted position the knife remains fully functional for its intended use.

Device

CATARACT PACK
  • Model / Serial
    Model Catalog: SEY30CTSBG (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CTCWB (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CSSJD (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CASJN (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CACOL (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CSSJB (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Product Description
    CATARACT PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC