Events

Recall of PROWICK SHOULDER POSTOPERATIVE DRESSING & COLD THERAPY SYSTEM

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
    96456
  • Event Risk Class
    II
  • Event Initiated Date
    2007-03-26
  • 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
    During routine new product testing it was discovered that the product although sterilized in accordance with validated parameters may not be sterile.

Device

PROWICK SHOULDER POSTOPERATIVE DRESSING & COLD THERAPY SYSTEM
  • Model / Serial
    Model Catalog: AR-1625 (Lot serial: D632517 Identifier AR-1625)
  • Product Description
    PROWICK SHOULDER POSTOPERATIVE DRESSING
  • Manufacturer
    LASSWELL MEDICAL CO. LTD.

Manufacturer

LASSWELL MEDICAL CO. LTD.