Field Safety Notices about Wallach LL100 Cryosurgical System CO2 and Accessories

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Wallach Surgical Devices.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2010(01)
  • Date
    2010-02-18
  • Event Country
  • Event Source
    HPRA
  • Event Source URL
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    A manufacturing problem has been detected where under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimum temperature delivery to the treatment site.
  • Action
    1) Ensure the appropriate personnel are made aware of this notice.  2) Identify the location of all Wallach LL100 Cryosurgical System CO2 and Accessories.  3) Follow the instructions outlined in the attached FSN from Wallach Surgical regarding this action.

Device

  • Model / Serial
  • Product Description
    Wallach LL100 Cryosurgical System CO2 and Accessories
  • Manufacturer

Manufacturer