International Medical Devices Database

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.

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Type of Event
Field Safety Notice
Event Number
SN2010(01)
Date
2010-02-18
Event Country
Ireland
Event Source
HPRA
Event Source URL
http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/wallach-ll100-cryosurgical-system-co2-and-accessories&id=fe8bf825-9782-6eee-9b55-ff00008c97d0
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

Wallach LL100 Cryosurgical System CO2 and Accessories

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

Manufacturer

Wallach Surgical Devices

Manufacturer Parent Company (2017)
The Cooper Companies, Inc.
Source
HPRA

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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Field Safety Notices about Wallach LL100 Cryosurgical System CO2 and Accessories

What is this?

Device

Wallach LL100 Cryosurgical System CO2 and Accessories

Manufacturer

Wallach Surgical Devices