Events

Field Safety Notices about Non-sterile Assut Sutures AssuCryl and Silk Surgical Sutures

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

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(21)
  • Date
    2011-08-19
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/non-sterile-assut-sutures-assucryl-and-silk-surgical-sutures&id=3e83f825-9782-6eee-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
    Stolen non-sterile assut sutures assucryl and silk surgical sutures are labelled as “sterile”.
  • Action
    The IMB advises that you:  • Check your inventory for the affected product.  • Monitor all incoming shipments for the affected product.  • If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, do not use the devices and contact Assut Medical Sàrl.  • If healthcare professionals suspect or know that the stolen non-sterile devices have been used, it is recommended that they monitor and treat patients accordingly.

Device

Non-sterile Assut Sutures AssuCryl and Silk Surgical Sutures
  • Model / Serial
  • Product Description
    Non-sterile Assut Sutures AssuCryl and Silk Surgical Sutures
  • Manufacturer
    Assut Medical Sàrl

Manufacturer

Assut Medical Sàrl