Events

Field Safety Notices about Needle Guide 12-18 GA, Needle Guide Starter Kit, Biopsy Starter Kit, Sales Demo Kit

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 CIVCO Medical Instruments CO., Inc. dba CIVCO.

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
    568
  • Date
    2016-05-25
  • 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

Needle Guide 12-18 GA, Needle Guide Starter Kit, Biopsy Starter Kit, Sales Demo Kit
  • Model / Serial
    Catalog Number: Infiniti Plus Needle Guide 12-18 GA: 610-1215,610-1235, 610-1235-5, 610-1234, 610-1236 Needle Guide Starter Kit:674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061 Biopsy Starter Kit: 10787043, 11001906, 613-247, 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-127, 667-132, 672-001 Sales Demo Kit: DEMOGPGUIDE 698-007 698-009 698-013 698-015 742-397-T 742-416 H48392LT 667-132 Batch Number: Šarže mezi M030030 až M665970 a M998920 uvedené na krabicích nebo vyrobené mezi 02/2013 až 01/2015
  • Product Description
    Medical devices for single use
  • Manufacturer
    CIVCO Medical Instruments CO., Inc. dba CIVCO

Manufacturer

CIVCO Medical Instruments CO., Inc. dba CIVCO