Events

Recall of ARTHROWAND 90 DEGREE W/O SUCTION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LASSWELL MEDICAL CO. 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
    85058
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-25
  • 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
    Arthrocare corporation has determined that several lots of the saber 30 with integrated cable wands are subject to excessive movement in its plastic tray during shipping. the wands are not secured in the plastic tray and the movement can potentially render the product non-sterile in cases where the tip of the wand wears a small puncture or hole in the tyvek lid.

Device

ARTHROWAND 90 DEGREE W/O SUCTION
  • Model / Serial
    Model Catalog: AC4330-01 (Lot serial: 10 lotscontact manufacturer)
  • Product Description
    SABER 30 ICW 3.0MM 30 DEGREES
  • Manufacturer
    LASSWELL MEDICAL CO. LTD.

Manufacturer

LASSWELL MEDICAL CO. LTD.