Events

Recall of CUSTOM STERILE RADICAL PROSTATE 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
    129727
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-02
  • 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
    This recall has been intiated because ethicon has revised its directions for convenience kit manufactures such that these products can no longer be placed in kits that will undergo ethylene oxide sterilization. the revision in direction is based on a chage in the product packaging. the ethicon sturues contained in the affected packs have undergone re-steriliation with ethylene oxide potentially causing a recution in tensile strength.

Device

CUSTOM STERILE RADICAL PROSTATE PACK
  • Model / Serial
    Model Catalog: SOT30RPVRF (Lot serial: ); Model Catalog: SAN30LHTGB (Lot serial: )
  • Product Description
    CUSTOM STERILE RADICAL PROSTATE PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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