Events

Field Safety Notices about Unomedical Sterile Urine Drainage Bags

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Unomedical.

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 Number
    SN2011(18)
  • Date
    2011-07-19
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/unomedical-sterile-urine-drainage-bags&id=0797f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    Unomedical a/s has become aware that in certain sterile urine drainage bags, there is potential that the connector between the catheter and bag may be blocked.
  • Action
    The manufacturer and the distributors of this device in Ireland have been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA).  The IMB advises that users:  • Follow the manufacturer’s recommendations as outlined in the attached FSN.  • Identify the affected devices in your facility and contact the manufacturer to arrange for return.

Device

Unomedical Sterile Urine Drainage Bags
  • Model / Serial
  • Product Description
    Unomedical Sterile Urine Drainage Bags
  • Manufacturer
    Unomedical

Manufacturer

Unomedical