Events

Field Safety Notices about ACDA-A (Anticoagulant Citrate Dextrose Solution)

According to Turkey Drugs and Medical Devices Agency (Titck), this field safety notices involved a device in Turkey that was produced by Biomet Inc..

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
    2016/804 & HHE CL 15-001
  • Date
    2016-08-03
  • Event Country
    Turkey
  • Event Source
    TDMDAT
  • Event Source URL
    https://web.archive.org/web/20170817101933/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-804%20SGB.pdf
  • Notes / Alerts
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Extra notes in the data

Device

ACDA-A (Anticoagulant Citrate Dextrose Solution)
  • Model / Serial
  • Product Description
    Class IIB
  • Manufacturer
    Biomet Inc.

Manufacturer

Biomet Inc.
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    TDMDAT