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
Event ID
MDA/2013/083
Event Number
CON354193
Date
2013-12-13
Event Date Posted
2013-12-13
Event Country
United Kingdom
Event Source
MHRA
Event Source URL
https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON354193?tabName=allTabs
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
Risk of delay to patient treatment. arrow international are recalling certain models and lot numbers of their transradial artery access kits because the introducer needles packaged within the kits can be partially or fully occluded. arrow international issued a field safety notice (fsn) dated 9 october 2013. the fsn lists the part and lot numbers that are affected. the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
Action
Identify and quarantine affected kits pending return to Teleflex Medical. Ensure that all users are aware of the advice given in the Arrow International FSN for identifying and returning affected stock. Fill in the acknowledgement form in the FSN and return it to Teleflex Medical.

Device

TransRadial artery access kit

Model / Serial
Product Description
TransRadial artery access kit. (a division of Teleflex Medical). Specific part numbers and lot numbers.
Manufacturer
Arrow International

Manufacturer

Arrow International

Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
MHRA

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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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Safety Alert Or Field Safety Notices for TransRadial artery access kit

What is this?

Device

TransRadial artery access kit

Manufacturer

Arrow International