Events

Recall of Captura Disposable Biopsy Forceps (endotherapy forceps, flexible, single use)

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-2012-RN-00785-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00785-3
  • 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
    The forceps inside the packaging may be the incorrect configuration. specifically, the outer packaging indicates the product is dbf-2.4sn-230-s (has non-spiked forceps head), but the forceps inside are actually dbf-2.4sl-230sp-s (has spiked large forceps head).
  • Action
    Quarantine and return affected devices to Cook Medical.

Device

Captura Disposable Biopsy Forceps (endotherapy forceps, flexible, single use)
  • Model / Serial
    Captura Disposable Biopsy Forceps (endotherapy forceps, flexible, single use)Reorder Number: DBF-2.4SN-230-S (16 boxes of 10)Lot Number: W3074075ARTG Number: 176865
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd