Events

Recall of WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY SET MALLINCKRODT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (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
    104598
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-20
  • 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
    Cook has identified that the affected lots may contain wire guides that were incorrectly loaded into the wire guide holder. this could lead to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Device

WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY SET MALLINCKRODT
  • Model / Serial
    Model Catalog: WOGS-1400-MKDT-A (Lot serial: G08417); Model Catalog: WOGS-1200-WH-050493 (Lot serial: G07637); Model Catalog: WOGS-1200-WH-050493 (Lot serial: G05274)
  • Product Description
    WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY SET MALLIN;WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY SET
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.