Events

Field Safety Notices about STERILE WINDING 18G

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Kimal Plc.

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
  • Date
    2016-06-03
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Kimal received a complaint from one party that the above product was inconsistent when sealing the bag. after an internal inspection of the stored specimens, we identified some instances where the pouch was not sealed in the corner where it normally opens, meaning that the product is no longer sterile. we kindly ask you to review your stock of the above mentioned product and batch numbers. if you find that the bag is not sealed, remove the product in question from your stock and discard it. tell kimal how many products you have discarded and you will receive free replacement items. the photos below show a seal error and acceptable seal:.

Device

STERILE WINDING 18G

Manufacturer

Kimal Plc