Events

Recall of Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier

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-00539-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00539-1
  • 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
    The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance.There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices.
  • Action
    Users are requested to: 1. Review the list provided in the customer letter and examine inventory immediately to identify; and quarantine any affected products. 2. Complete and return the Acknowledgement and Receipt form provided as soon as possible. Users are further advised that supply of these products will be discontinued in Australia.

Device

Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra...
  • Model / Serial
    Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier Catalogue Identifier: 090002All LotsStamey NeedleCatalogue Identifier: 095030, 095015 and 095000All LotsClarke-Reich Laparoscopic Knot PusherCatalogue Identifier: J-CRKP-042900All LotsARTG Numbers: 212233 and 166926
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd