Events

Recall of Ansell Sandel Weighted Safety Scalpel

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ansell Ltd T/A Ansell Healthcare.

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-2013-RN-01152-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01152-1
  • 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 manufacturer has received reports where certain lots of ansell sandel weighted safety scalpels are packaged with the scalpel blade exposed beyond the safety shield. the exposure of the tip could compromise the integrity of the package and the sterility of the scalpel.
  • Action
    Ansell is requesting users to quarantine affected lots and return to Ansell for replacement or credit.

Device

Ansell Sandel Weighted Safety Scalpel
  • Model / Serial
    Ansell Sandel Weighted Safety ScalpelBatch Number: 2211-NLot Number: LN 2782Expiry Date: Sep 2015Batch Number: 2210-LLot Number: LN 0662, LN 2052Expiry Date: Mar 2015, Jun 2015Batch Number: 2215-NLot Number: LN 1203Expiry Date: Mar 2016Batch Number: 2211-LLot Numbers: LN 0662, LN 2962Expiry Dates: Mar 2015, Sep 2015Batch Number: 2215-LLot Number: LN 2052, LN 1203Expiry Date: Jun 2015, Mar 2016ARTG Number: 196914
  • Manufacturer
    Ansell Ltd T/A Ansell Healthcare

Manufacturer

Ansell Ltd T/A Ansell Healthcare