Events

Recall of Disposable Reuter Tip-Deflecting Wire Guide

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

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
    RC-2017-RN-01390-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01390-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Cook medical has identified that the labels of specific lots of disposable reuter tip-deflecting wire guides do not explicitly state that they are heparin coated. the products are labelled with the correct catalogue identifier, which includes the suffix “bh” that indicates the product is heparin coated. however, users who are not familiar with the “bh” nomenclature may not be aware that the product contains heparin.To date, no adverse events have been reported due to this issue. under rare circumstances, these products could unknowingly be used in a patient with a heparin allergy or a patient with a history of heparin induced thrombocytopenia (hit). either of these situations could potentially result in serious injury or death.
  • Action
    Cook Medical is advising users to inspect stock and quarantine remaining units for replacement with unaffected stock.

Device

Disposable Reuter Tip-Deflecting Wire Guide
  • Model / Serial
    Disposable Reuter Tip-Deflecting Wire GuideCatalogue Identifier (Prefix/Suffix): DTDW-/-BHLot Numbers: F4791428, F4791430, NS5562947 and F4791427Supplied under Special Access Scheme (SAS)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd