Events

Recall of Scalpel in Lifemed Procedure Packs

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard 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-2018-RN-00267-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00267-1
  • 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
    Product complaints received by bard australia reported that the safety sheath covering the scalpel blade (component number in1951) was found in a very low number of lifemed procedure packs as being not engaged, resulting in an exposed blade that could inadvertently lead to a cut during manual handling by health care professionals, especially in circumstances where they are unaware of this anomaly whilst opening the pack.This issue does not impact the sterility of the packs.
  • Action
    Users are being made aware of this issue and asked to take extra care when opening the procedure packs. Affected units may be returned at the discretion of the customer on a case by case basis.

Device

Scalpel in Lifemed Procedure Packs
  • Model / Serial
    Scalpel in Lifemed Procedure PacksComponent: IN1951Multiple Product Codes and Lot NumbersARTG Numbers: 180554 Bard Australia - Surgical procedure kit, general- purpose, single-use, non-medicated;180555 Bard Australia - Angiographic kit;189114 Bard Australia - Lifemed Angiography Pack with Guidewire - Angiographic kit; and193043 Bard Australia - Surgical procedure kit, general-purpose, single-use, non-medicated
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd