Events

Recall of ELEFANT SUCTION-IRRIGATION DEVICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COLOPLAST MANUFACTURING US LLC.

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
    15809
  • Event Risk Class
    II
  • Event Initiated Date
    2007-11-08
  • 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 sterilization of the product is not performed according to iso 11135 standards. coloplast is not able to guarantee the sterility of the product.

Device

ELEFANT SUCTION-IRRIGATION DEVICE
  • Model / Serial
    Model Catalog: (Lot serial: ASP 150); Model Catalog: (Lot serial: ASP 145); Model Catalog: (Lot serial: ASP 105); Model Catalog: (Lot serial: ASP 125); Model Catalog: (Lot serial: ASP 110); Model Catalog: (Lot serial: ASP 135); Model Catalog: (Lot serial: ASP 165); Model Catalog: (Lot serial: ASP 155); Model Catalog: (Lot serial: AST TUBING); Model Catalog: (Lot serial: ASP 180); Model Catalog: (Lot serial: ASP 170)
  • Product Description
    ELEFANT SUCTION-IRRIGATION DEVICE
  • Manufacturer
    COLOPLAST MANUFACTURING US LLC

Manufacturer

COLOPLAST MANUFACTURING US LLC
  • Manufacturer Address
    MINNEAPOLIS
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    HC