Events

Recall of STAINLESS SAFETY SCALPEL 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
    28607
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-17
  • 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
    Inspection of finished product lots identified a single unit inside the boxes that exhibited a partial seal. this issue is due to a potential of unsealed sterile pouches.

Device

STAINLESS SAFETY SCALPEL STERILE
  • Model / Serial
    Model Catalog: 73-0611 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 73-0610 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 73-0615 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    STAINLESS SAFETY SCALPEL STERILE
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.