Events

Recall of General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure Pack

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medline International Two 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-2016-RN-00882-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00882-1
  • 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
    This letter is to inform users that medline is recalling two procedure packs, the general laparoscopy and the gynecological laparoscopy, as they contain a conmed core suction irrigation handpiece. medline was informed by conmed that the core suction irrigation handpiece may contain creases in the packaging seal which sometimes results in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as a result of this issue.
  • Action
    Medline is advising users to check the procedure packs in stock, remove and retain the ConMed CORE suction Irrigation Handpiece for return. Medline will replace the affected handpieces with unaffected stock. This action has been closed-out on 20/01/2017.

Device

General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE ...
  • Model / Serial
    General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure PackProduct Codes: CSBABRMQ18A and CSBABRMQ18BGynecological Laparoscopy Procedure Pack Product Codes: CSMABRMQ10A and CSMABRMQ10BARTG Number: 137395
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd