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
Safety alert / Field Safety Notice
Date
2018-07-06
Event Date Posted
2018-07-05
Event Country
United Kingdom
Event Source
MHRA
Event Source URL
https://www.gov.uk//drug-device-alerts/sam-xt-extremity-tourniquet-recall-due-to-the-risk-of-tourniquet-failing-in-use
Notes / Alerts

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
Extra notes in the data
Reason
Manufactured by sam medical products - an error in the manual sewing operations of devices manufactured from march 2017 to april 2018 may cause the seam holding the buckle to the belt to fail.
Action
Refer to the manufacturer’s FSN for a list of affected lot numbers. Identify and quarantine affected devices. Return any affected devices and the completed recall response form to the distributor.

Device

SAM XT Extremity Tourniquet

Model / Serial
Product Description
SAM Medical Products: SAM XT Extremity Tourniquet
Manufacturer
SAM Medical Products

Manufacturer

SAM Medical Products

Manufacturer Parent Company (2017)
Sam Medical Products
Source
MHRA

About this database

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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Safety Alert Or Field Safety Notices for SAM XT Extremity Tourniquet

What is this?

Device

SAM XT Extremity Tourniquet

Manufacturer

SAM Medical Products