Events

Field Safety Notices about Cook Incorporated: Aprima ™ Non-Vascular Intervention Access Set, Beacon® Centimeter Centimeter Sizing Catheter, Beacon® Royal Flush® Plus High-Flow Catheter, Beacon® Torcon NB® Advantage Catheter, Beacon® Centimeter Sizing Catheter, White Beacon®-sized vascular catheter, Transjugular intrahepatic portal access set Haskal, Set of liver access and biopsy needles, Shuttle® Select Slip-Cath catheters, Slip-Cath® Beacon® tip catheters, Transluminal biliary biopsy set, White Lumax® guiding coaxial catheter, William Cook Europe Aps: Zenith Alpha ™ Endovascular Graft Set, Zenith Alpha ™ Endovascular Gland Set, Zenith Alpha® Endovascular Gland Set, Zenith Alpha® Endovascular Gland Kit, AAA Endovascular Gland Starter Kit Zenith® , Endovascular Endoscopic Set Zenith® t-Branch , Standard Set of Thoracic Endovascular Graft Zenith®

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by William Cook Europe ApS, Cook Incorporated.

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 ID
600
Date
2016-06-15
Event Country
Czechia
Event Source
MHSIDCCCDMIS
Event Source URL
https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
Notes / Alerts

Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
Extra notes in the data

Device

Cook Incorporated: Aprima ™ Non-Vascular Intervention Access Set, Beacon® Centimeter Centimeter S...

Model / Serial
Catalog Number: viz FSN
Product Description
Medical devices for single use
Manufacturer
William Cook Europe ApS, Cook Incorporated

Manufacturer

William Cook Europe ApS, Cook Incorporated

Manufacturer Parent Company (2017)
Cook Group Incorporated
Source
MHSIDCCCDMIS

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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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