Events

Safety Alert Or Field Safety Notices for Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retractable needle insulin

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Medicina Ltd.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/033
  • Event Number
    CON448008
  • Date
    2014-08-20
  • Event Date Posted
    2014-08-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON448008?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
    The affected devices are unable to deliver fewer than 7 units of insulin. in addition, the safety and performance of these devices has not been properly evaluated and so the ce marking of all of these devices is invalid. medicina issued a field safety notice in june 2014 but has not had sufficient confirmation that customers have received and acted on these notices.
  • Action
    Do not use affected devices. Quarantine them and contact Medicina Ltd to arrange for their collection. Return the email / fax back form in the FSN to the manufacturer. Personnel involved in the purchase, supply and distribution of these devices.

Device

Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retract...
  • Model / Serial
  • Product Description
    Insulin syringe 1ml safety syringe 27G (for professional use). Product code: RN01/27i. All batches. If relevant to you, the NHS Supply Chain Code is as follows: Medicina product code NPC Product description RN01/27i FWD150 Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retractable needle insulin
  • Manufacturer
    Medicina Ltd

Manufacturer

Medicina Ltd
  • Manufacturer Parent Company (2017)
    Luan Srl
  • Source
    MHRA