Events

Recall of WEIGHTED SAFETY SCALPEL BLADE STERILE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOUTHMEDIC INC..

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
    55665
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Ansell had received several complaints regarding the scalpels in question. it was determined that the safety mechanism is not fully engaged and the blade tip could breach the packaging. this posses a safety issues for patients as this is a breach of the sterile barrier. in addition the user could be injured on the exposed blade.

Device

WEIGHTED SAFETY SCALPEL BLADE STERILE
  • Model / Serial
    Model Catalog: 2215-N (Lot serial: Lot #1203); Model Catalog: 2215-N (Lot serial: >10 number contact mfg)
  • Product Description
    Ansell Sandel's Weighted Safety Scalpels
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.