Events

Field Safety Notices about STERRAD Booster, STERRAD Adaptor

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by ADVANCED STERILIZATION PRODUCTS.

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
    2013-11-20
  • Event Date Posted
    2013-12-16
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/12/16/vazno-obavestenje-o-medicinskom-sredstvu-2/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The purpose of this announcement is to inform you that asp has identified inconsistencies between the lumen claims listed in the sterrad® booster, sterrad® ifu adapter (la-104421-02 rev. a) and the lumen claims listed in the sterrad® 50, 100s and 200 systems. this could cause confusion for users when to use the sterrad® booster and when to use the sterrad® adapter. failure to use the booster and adapter when needed can potentially result in the lumen not being sterile. using an enhancer or adapter when not needed can result in the formation of residual hydrogen peroxide in the lumen.

Device

STERRAD Booster, STERRAD Adaptor

Manufacturer

ADVANCED STERILIZATION PRODUCTS