Events

Recall of WALLACH LL100/LL50X

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
    27156
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-03
  • 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
    Coopersurgical recently completed validation of a new disinfection procedure and the wallach ll100 cryosurgery system directions for use (dfu) has been updated. furthermore coopersurgical has determined that the useful life of the affected product is 5 years based on a 650 maximum reprocessing cycles.

Device

WALLACH LL100/LL50X
  • Model / Serial
    Model Catalog: 900020 (Lot serial: All lots); Model Catalog: 900001 (Lot serial: All lots); Model Catalog: 900002 (Lot serial: All lots); Model Catalog: 900150 (Lot serial: All lots); Model Catalog: 900162 (Lot serial: All lots); Model Catalog: 900629 (Lot serial: All lots); Model Catalog: 900502-4 (Lot serial: All lots); Model Catalog: 900630 (Lot serial: All lots); Model Catalog: 900506-2-N2O (Lot serial: All lots); Model Catalog: 900506-1-N2O (Lot serial: All lots); Model Catalog: 900001A-NO2 (Lot serial: All lots); Model Catalog: 900506-2-CO2 (Lot serial: All lots)
  • Product Description
    WALLACH LL100 TWO-TRIGGER CRYOSURGICAL UNIT FOR N2O
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.